Do Phosphodiesterase Type 5 Inhibitors Increase the Risk of Biochemical Recurrence After Radical Prostatectomy?

PURPOSE: There have been conflicting studies on the association between phosphodiesterase type 5 inhibitor (PDE5i) use and biochemical recurrence (BCR) following radical prostatectomy (RP). Our aim was to determine whether PDE5i drug exposure after RP increases the risk of BCR in patients undergoing RP. MATERIALS AND METHODS: An institutional database of prostate cancer patients treated between January 2009 and December 2020 was reviewed. BCR was defined as 2 PSA measurements greater than 0.1 ng/mL. PDE5i exposure was defined using a 0 to 3 scale, with 0 representing never use, 1 sometimes use, 2 regularly use, and 3 routinely use. The risk of BCR with any PDE5i exposure, the quantity of exposure, and the duration of PDE5i exposure were assessed by multivariable Cox proportional hazards models. RESULTS: The sample size included 4630 patients to be analyzed, with 776 patients having BCR. The median follow-up for patients without BCR was 27 (IQR 12, 49) months. Eighty-nine percent reported taking a PDE5i at any time during the first 12 months after RP, and 60% reported doing so for 6 or more months during the year after RP. There was no evidence of an increase in the risk of BCR associated with any PDE5i use (HR 1.05, 95% CI 0.84, 1.31, P = .7) or duration of PDE5i use in the first year (HR 0.98 per 1 month duration, 95% CI 0.96, 1.00, P = .055). Baseline oncologic risk was lower in patients using PDE5i, but differences between groups were small, suggesting that residual confounding is unlikely to obscure any causal association with BCR. CONCLUSIONS: Prescription of PDE5i to men after RP can be based exclusively on quality of life considerations. Patients receiving PDE5is can be reassured that their use does not increase the risk of BCR.

Cognitive effects of long-term androgen deprivation therapy in older men with prostate cancer.

OBJECTIVE: Androgen deprivation therapy (ADT) is a common treatment for prostate cancer (PCa), with increasing numbers of men on ADT for longer. Limited evidence suggests ADT impacts cognition. This study addressed gaps in the literature by focusing on older men with PCa and assessing ADT usage longer than 1 year. METHODS: This study of 133 men ≥65 years of age with PCa included two groups: (1) men on ADT for 1-3 years (ADT-exposed), and (2) a comparison group of men with PCa not on ADT (ADT-unexposed). Group comparisons on individual neuropsychological test scores are reported, as well as effect sizes (Cohen's d). RESULTS: Half (n = 67) of the sample was ADT-exposed and half (n = 66) were unexposed. The average age was 72 years, most were White, and over 50% had at least secondary education. There were no statistically significant differences between groups by age, race, or education. Unadjusted analyses showed the ADT-exposed group, compared with the ADT-unexposed group, performed significantly lower in domains of verbal learning (d = 0.45-0.52, p = 0.01 to <0.01), verbal recall (d = 0.33-0.54, p = 0.06 to <0.01), and possible effects in visuospatial construction (d = 0.33, p = 0.08 to 0.06). When controlling for age and education, similar patterns emerged. The ADT exposed-group performed significantly lower in domains of verbal learning (d = 0.45-0.52, p = 0.06 to 0.03) and verbal recall (d = 0.33-0.54, p = 0.11 to 0.03), and possible effects in visuospatial construction d = 0.33, p = 0.18 to 0.13. CONCLUSIONS: This study suggests long-term ADT exposure impacts verbal learning, verbal recall, and possibly visuospatial abilities in older men (≥65) with PCa. The potential cognitive effects of ADT should be discussed with older patients considering long-term use of ADT.

A survey of statistical methods utilized for analysis of randomized controlled trials of behavioral interventions.

OBJECTIVES: Given the many statistical analysis options used for randomized controlled trials (RCTs) of behavioral interventions and the lack of clear guidance for analysis selection, the present study aimed to characterize the predominate statistical analyses utilized in RCTs in palliative care and behavioral research and to highlight the relative strengths and weaknesses of each of these methods as guidance for future researchers and reform. METHODS: All RCTs published between 2015 and 2021 were systematically extracted from 4 behavioral medicine journals and analyzed based on prespecified inclusion criteria. Two independent raters classified each of the manuscripts into 1 of 5 RCT analysis strategies. RESULTS: There was wide variation in the methods used. The 2 most prevalent analyses for RCTs were longitudinal modeling and analysis of covariance. Application of method varied significantly by sample size. SIGNIFICANCE OF RESULTS: Each statistical analysis presents its own unique strengths and weaknesses. The information resulting from this research may prove helpful for researchers in palliative care and behavioral medicine in navigating the variety of statistical methods available. Future discussion around best practices in RCT analyses is warranted to compare the relative impact of interventions in a more standardized way.

A psychoeducational intervention to improve sexual functioning in male rectal and anal cancer patients: A pilot randomized controlled trial study.

OBJECTIVES: Male rectal and anal cancer patients demonstrate high rates of sexual dysfunction. This pilot randomized controlled trial tested a psychoeducational intervention designed to improve psychosexual adjustment. METHODS: Rectal or anal cancer patients were randomized to a Sexual Health Intervention for Men (intervention) or to a referral and information control (control). The intervention included control activities plus 4 sexual health intervention sessions every 4-6 weeks and 3 brief telephone calls timed between these sessions. Assessments were completed pre-intervention (baseline) and 3 months (follow-up 1) and 8 months (follow-up 2) post-intervention. Differences were assessed with statistical significance and Cohen's d effect sizes (d = 0.2, small effect; d = 0.5, moderate effect; d = 0.8, large effect). RESULTS: Ninety subjects enrolled. Forty-three participants completed at least 1 follow-up assessment (intervention, n = 14; control n = 29). At follow-up 1, men in intervention, compared to control, improved on all domains of the International Index of Erectile Function (IIEF) (p < 0.001 to p < 0.05) and demonstrated large effects (d = 0.8 to d = 1.5). Similarly, at follow-up 2, changes in all domains of the IIEF except the orgasm domain were either statistically significant or marginally statistically significant (p = 0.01 to p = 0.08) and demonstrated moderate to large treatment effects for intervention versus control (d = 0.5 to d = 0.8). Men in the intervention, compared to control, demonstrated decreased sexual bother at follow-up 1 (p = 0.009, d = 1.1), while Self-Esteem and Relationship (SEAR) total scores and the SEAR sexual relationship subscale demonstrated moderate increases for intervention versus control (d = 0.4 to d = 0.6). SIGNIFICANCE OF RESULTS: This study provides initial evidence for combining a psychoeducational intervention with medical interventions to address sexual dysfunction following rectal and anal cancer. Trials register number: NCT00712751 (date of registration: 7/10/2008).

Considerations for Evaluating Older Adults with Cancer for Depression: A Qualitative Survey of Experts.

OBJECTIVES: The objective of this study was to engage national experts in geriatric psychiatry and oncology in qualitative interviews to develop consensus regarding how older adult cancer survivors (OACS) experience depressive symptoms, and how best to assess OACs for depression. METHODS: Expert clinicians in geriatric oncology disciplines were interviewed about approaches to assessing depression in OACs. Interviews were audio-recorded and transcribed, and conducted until thematic saturation was achieved. Thematic Content Analysis was utilized to identify key themes. RESULTS: Experts (N = 8) were board certified geriatric psychiatrists and oncologists with specialization in geriatric medicine. Two conceptual domains were identified: Key indicators of depression in OACs (e.g. anhedonia; loss of meaning and purpose; loneliness and social withdrawal) and unique considerations for depression assessment in OACs (e.g. alternative phrasing to "depression," disentangling mood and cancer or treatment-related side effects). CONCLUSIONS: The approaches identified tended to depart from traditional diagnostic criteria for depression. CLINICAL IMPLICATIONS: Results provide additional insight into the limitations of existing depression measures for OACs. The themes and practices identified in the present study suggest that a revised measure of depression for OACs may be useful. Future research will continue to shed light on best practices for depression assessment in OACs.

Understanding the sexual health perceptions, concerns, and needs of female partners of prostate cancer survivors.

BACKGROUND: Prostate cancer (PCa) and its treatments can have a significant negative impact on the sexual health of survivors and couples, but few studies have specifically examined the impact of PCa-related sexual dysfunction on female partners of survivors. AIM: Our objective was to perform a qualitative study to comprehensively characterize female partners' perceptions of the implications of PCa on their sex lives, as well as partners' sexual health concerns and unmet needs. METHODS: We conducted semi-structured telephone interviews about sexual health and unmet needs with female partners of PCa survivors recruited from multiple clinical locations and support groups for PCa caregivers from September 2021 to March 2022. Interviews were audio-recorded, transcribed verbatim, and independently coded. Participants were recruited until thematic saturation was achieved. OUTCOMES: Outcomes of this study were female partner sexual health concerns and unmet needs. RESULTS: Among 12 participants, the median age was 65 (range 53 to 81) years, 9 were White, the median time since their partner's PCa diagnosis was 2.25 years (range 11 months to 20 years), and a majority reported that their partner had undergone radical prostatectomy, radiation, and/or hormonal therapy. Major emergent themes pertained to the significant impact of age- and PCa-related sexual dysfunction on female sexual quality of life, the dyadic nature of sexual dysfunction and recovery, the role of the partner in coping with and adjusting to sexual dysfunction, difficulties communicating about sexual dysfunction in an intimate relationship, a lack of physician-led sexual health counseling and support, and the benefit of peer interactions and proactive information seeking in addressing unmet sexual health needs. CLINICAL IMPLICATIONS: Future efforts should continue to explore the impact of PCa on partner sexual health and address unmet needs through sexual health education and support. STRENGTHS AND LIMITATIONS: In this study, we identified female partners' sexual health concerns both related to and independent of PCa survivor sexual health. Limitations include exclusion of male partners of survivors and potential responder bias, as partners who agreed to participate may have experienced more sexual health concerns. CONCLUSION: We found that female partners experience PCa-related sexual dysfunction as a couple's disease, grief due to age- and PCa-related sexual losses, and a lack of physician-led sexual health counseling and information. Our results highlight the importance of including partners of PCa survivors in the sexual recovery process and of developing sexual care programs to address partners' unmet sexual health needs.

Goal-Focused Emotion-Regulation Therapy (GET) in Young Adult Testicular Cancer Survivors: A Randomized Pilot Study.

BACKGROUND: Young adult testicular cancer survivors experience adverse impacts after treatment. We developed Goal-focused Emotion-regulation Therapy (GET) to improve distress symptoms, emotion regulation, and goal navigation skills. PURPOSE: This pilot study examined GET versus an active control intervention in young adult survivors of testicular cancer. METHODS: Seventy-five eligible survivors treated with chemotherapy were randomized to receive GET or Individual Supportive Listening (ISL). Study acceptability, engagement, and tolerability were examined, and intervention fidelity and therapeutic alliance were compared between arms. Preliminary efficacy was evaluated by effect sizes for between-group changes in primary (anxiety and depressive symptoms) and secondary (career confusion, goal navigation, and emotion regulation) outcomes from baseline to immediately and 3-month post-intervention. RESULTS: Among the 38 men randomized to GET, 81.1% completed all study sessions compared with 82.4% of the 37 men assigned to ISL. Fidelity to the intervention was 87% in GET. Therapeutic alliance wassignificantly higher among those receiving GET versus ISL. Participants exhibited a medium group-by-time effect size with greater reductions in depressive (d = 0.45) and anxiety (d = 0.29) symptoms for those in GET versus ISL, with a similar pattern at 3 months for depressive (d = 0.46) and anxiety (d = 0.46) symptoms. CONCLUSIONS: GET is a feasible and acceptable intervention for reducing adverse outcomes after testicular cancer for young adults. Observed effect sizes preliminarily suggest meaningful change, though should be interpreted with caution in small samples. GET may be a developmentally-matched behavioral approach to improve psychosocial function in this cancer group. CLINICAL TRIAL INFORMATION: Clinicaltrials.gov, NCT04150848. Registered on October 28, 2019.

Young adult testicular cancer survivors experience adverse impacts after treatment. Goal-focused Emotion-regulation Therapy (GET) was developed to improve distress symptoms, emotion regulation, and goal navigation skills. The aim of this pilot study was to examine GET versus a control intervention in young adult survivors of testicular cancer. Seventy-five survivors were randomly assigned to GET or Individual Supportive Listening (ISL). Indictors of acceptability, engagement, and tolerability were examined, and intervention fidelity and therapeutic alliance were compared between groups. Between-group changes in primary (anxiety and depressive symptoms) and secondary (career confusion, goal navigation, and emotion regulation) outcomes from baseline to immediately and 3-month post-intervention were examined. Among GET participants, 81.1% completed all study sessions compared with 82.4% of those receiving ISL. Fidelity to the intervention was 87% in GET. Therapeutic alliance scores were significantly higher among those receiving GET. Participants exhibited greater reductions in depressive and anxiety symptoms for those in the GET versus ISL, with a similar pattern observed for changes at 3 months for depressive and anxiety symptoms. GET is a feasible and acceptable intervention for reducing adverse outcomes after testicular cancer for young adults.

Exercise Associated with Cognitive Function in Older Men with Prostate Cancer Undergoing Androgen Deprivation Therapy.

BACKGROUND: To examine associations between exercise and cognitive function in older men undergoing hormone therapy for prostate cancer. METHOD: Men ≥ 65 years old with prostate cancer, currently undergoing androgen deprivation therapy for ≥ 6 months (n = 50), completed the Godin-Shephard Leisure-Time Physical Activity Questionnaire, and standard neuropsychological tests. Pearson's correlations and linear regressions were used to examine associations between exercise and cognitive performance. RESULTS: Exercise was significantly positively correlated with performance on tests of memory, attention, and executive function. Linear regressions showed that when controlling for age and education, exercise remained a significant predictor of attention and executive function performance (p < 0.05), and showed moderate, but statistically non-significant effects on memory performance (p < 0.10). CONCLUSION: Greater exercise is associated with better functioning in multiple cognitive domains in men with prostate cancer undergoing hormone therapy, providing proof-of-concept evidence that exercise may be a feasible intervention to limit cognitive dysfunction in prostate cancer patients.

On taking up space: a qualitative inquiry of depression in older adults with cancer.

OBJECTIVE: To identify the phenomenology of depression in older adults with cancer (OACs) in order to improve the accuracy of depression screening for this population. METHOD: Inclusion criteria were: ≥70 years old, history of cancer, no cognitive impairment or severe psychopathology. Participants completed a demographic questionnaire, a diagnostic interview, and a qualitative interview. Using a Thematic Content Analysis framework, critical themes, passages, and phrases used by patients to describe their perceptions of depression and how it is experienced were identified. Particular attention was paid to divergences between depressed and non-depressed participants. RESULTS: Among 26 OACs (13 depressed, 13 non-depressed), qualitative analyses revealed four major themes indicative of depression (i.e. anhedonia, reduction in social relationships/loneliness, lack of meaning and purpose, lack of usefulness/feeling like a burden) and four minor themes (i.e. attitude towards treatment, mood, regret/guilt, physical symptoms/limitations). Themes of adaptation and acceptance of symptoms also emerged. CONCLUSIONS: Of the eight themes identified, only two overlap with DSM criteria. This supports the need to develop assessment methods of depression in OACs that are less reliant on DSM criteria and distinct from existing measures. This may improve the ability to identify depression in this population.

Cancer-related inflammation and depressive symptoms: Systematic review and meta-analysis.

BACKGROUND: Depressive symptoms in patients with cancer are associated with poor quality of life and decreased survival. Although inflammation is reliably associated with depression in otherwise healthy individuals, the association in patients with cancer remains unclear. Given the high prevalence of cancer-related inflammation, the authors aimed to establish the relationship between inflammation and depression in cancer patients based on extant literature. METHODS: A systematic review and meta-analysis was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines and registered under Prospero ID CRD42021226743. Three databases were searched including PubMed, the Cochrane Library, and PsycINFO using the following criteria for inclusion: 1) measurement of a peripheral inflammatory marker, 2) use of a validated tool/scale to measure depression, and 3) a cancer diagnosis. Risk of publication bias was assessed by Funnel plot and Egger test. RESULTS: Seventy-three studies were included in the systematic review and 54 studies (n = 5017) were included in meta-analyses. Associations with depressive symptoms were significant for peripheral blood interleukin (IL)-6 (standardized mean difference [SMD] = 0.59; 95% confidence interval [CI], 0.35-0.82), I2  = 57.9%; tumor necrosis factor (TNF) (SMD = 0.73; 95% CI, 0.35-1.11), I2  = 74.1%; and C-reactive protein (CRP) (SMD = 0.57; 95% CI, 0.27-0.87), I2  = 0%. IL-5, IL-13, albumin, and neutrophil-to-lymphocyte ratio were associated with depressive symptoms but based on fewer studies. Most cancer settings were represented; the number of studies per inflammatory marker varied from 1 to 52. CONCLUSIONS: Although peripheral inflammatory markers were unevenly studied, the most studied markers (IL-6, TNF, and CRP) were associated with depressive symptoms in cancer patients and may be useful for management of depressive symptoms in the cancer setting. LAY SUMMARY: Peripheral blood inflammatory markers (IL-6, TNF, and CRP) were associated with depressive symptoms in various cancer settings. Although further studies are warranted, these findings may help identify and manage depressive symptoms in patients with cancer.

TrueNTH Sexual Recovery Intervention for couples coping with prostate cancer: Randomized controlled trial results.

BACKGROUND: Despite significant sexual dysfunction and distress after localized prostate cancer treatment, patients typically receive only physiologic erectile dysfunction management. The authors performed a randomized controlled trial of an online intervention supporting couples' posttreatment recovery of sexual intimacy. METHODS: Patients treated with surgery, radiation, or combined radiation and androgen deprivation therapy who had partners were recruited and randomized to an online intervention or a control group. The intervention, tailored to treatment type and sexual orientation, comprised 6 modules addressing expectations for sexual and emotional sequelae of treatment, rehabilitation, and guidance toward sexual intimacy recovery. Couples, recruited from 6 sites nationally, completed validated measures at the baseline and 3 and 6 months after treatment. Primary outcome group differences were assessed with t tests for individual outcomes. RESULTS: Among 142 randomized couples, 105 patients (mostly surgery) and 87 partners completed the 6-month survey; this reflected challenges with recruitment and attrition. There were no differences between the intervention and control arms in Patient-Reported Outcomes Measurement Information System Global Satisfaction With Sex Life scores 6 months after treatment (the primary outcome). Three months after treatment, intervention patients and partners reported more engagement in penetrative and nonpenetrative sexual activities than controls. More than 73% of the intervention participants reported high or moderate satisfaction with module content; more than 85% would recommend the intervention to other couples. CONCLUSIONS: Online psychosexual support for couples can help couples to connect and experience sexual pleasure early after treatment despite patients' sexual dysfunction. Participants' high endorsement of the intervention reflects the importance of sexual health support to couples after prostate cancer treatment. LAY SUMMARY: This study tested a web-based program supporting couples' sexual recovery of sexual intimacy after prostate cancer treatment. One hundred forty-two couples were recruited and randomly assigned to the program (n = 60) or to a control group (n = 82). The program did not result in improvements in participants' satisfaction with their sex life 6 months after treatment, but couples in the intervention group engaged in sexual activity sooner after treatment than couples in the control group. Couples evaluated the program positively and would recommend it to others facing prostate cancer treatment.

Luteinizing Hormone Suppression Profiles in Men Treated With Exogenous Testosterone.

BACKGROUND: Due to the negative feedback mechanism involved in the hypothalamic-pituitary-gonadal axis, testosterone therapy (TTh) may result in suppression of luteinizing hormone (LH) secretion, but clinical experience demonstrates the level of LH suppression is variable. AIM: We sought to define the relationship between TTh and LH levels, specifically predictors of LH suppression in men on TTh. METHODS: We performed a retrospective analysis of a prospectively maintained database of patients with testosterone deficiency (TD) treated with TTh. Patient demographic and clinical data including vascular risk factor (VRF) status were collected. Serum total T and LH levels before TTh and after ≥3 months (m) were recorded. LH suppression was defined as serum LH level <1.0 IU/ml. MAIN OUTCOME MEASURES: Predictors of LH suppression were searched though a series of logistic regression models assessing suppression status at the final observation, and then a series of Cox proportional hazards models assessing time to first suppression were performed. RESULTS: A total of 227 patients with mean age of 58±14 years at time of TTh initiation were included in our analysis. Just under half of subjects received transdermal T as the only modality (n = 101, 44%), while one third (n = 77, 34%) received intramuscular only, and the remainder (n = 49, 22%) received both modalities during follow-up. The mean baseline LH level was 10 ± 12 IU/ml. The percent of men who had baseline LH level above 1 IU/ml and at any given point of TTh was 84% and 78%, respectively, thus 22% of men had suppressed LH levels on TTh considering the definition of LH <1 IU/ml. Most men (73%) had a suppressed LH level of <1 IU/ml at least once during follow-up. In the final adjusted model for LH suppression, intramuscular route (OR = 2.44), baseline LH (OR = 0.94), estradiol (OR = 1.05) remained significant. CLINICAL IMPLICATIONS: LH suppression profiles may be relevant for dose titration during TTh and perhaps to minimize testicular atrophy. STRENGTHS & LIMITATIONS: A strict definition for TD was applied using LCMS for T measurements and patients had long-term follow-up. CONCLUSION: While 73% of patients had at least one LH <1 IU/ml during TTh, only 22% maintained suppressed throughout the treatment. Miranda EP, Schofield E, Matsushita K, et al. Luteinizing Hormone Suppression Profiles in Men Treated With Exogenous Testosterone. J Sex Med 2022;19:1359-1365.

Unmet Sexual Health Needs of Patients and Female Partners Following Diagnosis and Treatment for Prostate Cancer.

BACKGROUND: Prostate cancer (PCa) and its treatment can have significant and pervasive sexual side effects for patients and their partners; however, partner needs are not well understood, and most resources do not incorporate partner priorities. AIM: Our objective was to perform a qualitative study to identify unmet sexual needs of patients and female partners after PCa diagnosis. METHODS: We conducted a qualitative study of posts to the Inspire Us TOO Prostate Cancer Online Support and Discussion Community. Overall, 6,193 posts were identified in the Sexual Health & Intimacy forum of the community, of which 661 posts were from female authors. A random sample of 10% (n = 66) of posts from female partners and an equal number of randomly selected posts from male patients were analyzed. OUTCOMES: We assessed sexual health themes among patients and female partners. RESULTS: Multiple themes emerged that were unique to female partners of PCa survivors. These included expanding the sexual repertoire, feeling invisible, contextualizing sexual intimacy within the broader picture of survival, and addressing relationship concerns. Patients and their partners also shared common sexual health themes, including coming to terms with changes in sexual function and frustration with clinicians. Both patients and their partners use online health communities to get support and share their experiences with sexual recovery and use of sexual aids. Psychosocial treatments were infrequently mentioned, and may be particularly helpful to address partner concerns. CLINICAL IMPLICATIONS: A common concern for couples was not receiving sufficient information from healthcare providers regarding sexual side effects from PCa and its treatment. STRENGTHS AND LIMITATIONS: Strengths of the study include leveraging a unique data source to address an understudied topic of sexual health concerns among partners after PCa diagnosis. However, members of an online community may not be representative of all couples facing PCa. Also, this analysis is limited to female partners of patients with PCa, and further study is underway to examine the sexual health needs among gay and bisexual couples. CONCLUSION: Both patients and female partners have many unmet sexual health needs during PCa survivorship, and designing interventions to incorporate partner perspectives may improve the management of sexual side effects of PCa for couples. Li R, Wittmann D, Nelson CJ, et al. Unmet Sexual Health Needs of Patients and Female Partners Following Diagnosis and Treatment for Prostate Cancer. J Sex Med 2022;19:1797-1803.

Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel.

BACKGROUND: Patients with prostate cancer suffer significant sexual dysfunction after treatment which negatively affects them and their partners psychologically, and strain their relationships. AIM: We convened an international panel with the aim of developing guidelines that will inform clinicians, patients and partners about the impact of prostate cancer therapies (PCT) on patients' and partners' sexual health, their relationships, and about biopsychosocial rehabilitation in prostate cancer (PC) survivorship. METHODS: The guidelines panel included international expert researchers and clinicians, and a guideline methodologist. A systematic review of the literature, using the Ovid MEDLINE, Scopus, CINAHL, PsychINFO, LGBT Life, and Embase databases was conducted (1995-2022) according to the Cochrane Handbook for Systematic Reviews of Interventions. Study selection was based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Each statement was assigned an evidence strength (A-C) and a recommendation level (strong, moderate, conditional) based on benefit/risk assessment, according to the nomenclature of the American Urological Association (AUA). Data synthesis included meta-analyses of studies deemed of sufficient quality (3), using A Measurement Tool to Assess Systematic Reviews (AMSTAR). OUTCOMES: Guidelines for sexual health care for patients with prostate cancer were developed, based on available evidence and the expertise of the international panel. RESULTS: The guidelines account for patients' cultural, ethnic, and racial diversity. They attend to the unique needs of individuals with diverse sexual orientations and gender identities. The guidelines are based on literature review, a theoretical model of sexual recovery after PCT, and 6 principles that promote clinician-initiated discussion of realistic expectations of sexual outcomes and mitigation of sexual side-effects through biopsychosocial rehabilitation. Forty-seven statements address the psychosexual, relationship, and functional domains in addition to statements on lifestyle modification, assessment, provider education, and systemic challenges to providing sexual health care in PC survivorship. CLINICAL IMPLICATIONS: The guidelines provide clinicians with a comprehensive approach to sexual health care for patients with prostate cancer. STRENGTHS & LIMITATIONS: The strength of the study is the comprehensive evaluation of existing evidence on sexual dysfunction and rehabilitation in prostate cancer that can, along with available expert knowledge, best undergird clinical practice. Limitation is the variation in the evidence supporting interventions and the lack of research on issues facing patients with prostate cancer in low and middle-income countries. CONCLUSION: The guidelines document the distressing sexual sequelae of PCT, provide evidence-based recommendations for sexual rehabilitation and outline areas for future research. Wittmann D, Mehta A, McCaughan E, et al. Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel. J Sex Med 2022;19:1655-1669.

African-centered coping, resilience, and psychological distress in Black prostate cancer patients.

OBJECTIVE: Blacks have the highest incidence and mortality rates for prostate cancer (PCa) in the U.S. Black PCa patients (PCaP) also report high psychological distress. Identifying culturally specific coping strategies that lower distress among Black PCaP could help improve psychological interventions for this group. African-centered coping (strategies unique to the structure of Black personality and the African-centered worldview) have been identified. We hypothesized that these coping strategies and resilience would be associated with lower psychological distress (anxiety and depression) in Black PCaP. METHODS: Black PCaP (N = 95) completed a survey assessing African-centered coping strategies, resilience, anxiety, and depression. Multiple regression was employed to examine African-centered coping strategies and resilience as predictors of psychological distress. RESULTS: Participants were aged M = 67 ± 9 years and 52% had late-stage PCa. Twenty percent met criteria for clinically significant anxiety, and 17% for depression. African-centered coping strategies were not associated with lower anxiety or depression, while resilience was associated with decreased anxiety (r = -0.45, p < 0.001) and depression (r = -0.54, p < 0.001). Mediation analyses did not support an indirect association among African-centered coping strategies, resilience, and anxiety and depression. CONCLUSIONS: Contrary to hypotheses, African-centered coping strategies were not associated with psychological distress. However, as predicted, greater resilience was associated with lower anxiety and depression. These findings support the relevancy of resilience in Blacks' psychological adjustment to PCa. It might be worthwhile to explore African-centered coping strategies that help Black PCaP cope with distress.

A Randomized, Controlled, 3-Arm Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function After Radical Prostatectomy.

BACKGROUND: Although the concept of penile rehabilitation after radical prostatectomy (RP) has been advocated for decades, there is little definitive evidence regarding its utility or the best strategy to optimize patient outcomes. AIM: The goal of this study is to analyze the ability of 3 different pharmacological strategies to preserve the ability of men to achieve spontaneous (non-medication assisted) erections after bilateral nerve-sparing RP. METHODS: This IRB- and FDA-approved study studied penile rehabilitation in a 3-arm fashion with a target enrollment of 200 patients. (i) Control arm: nightly placebo with sildenafil 100 mg on demand for sexual relations (up to 6 pills/month); (ii) nightly sildenafil arm: nightly sildenafil 50 mg and sildenafil 100 mg on demand for sexual relations (up to 6 pills/month); (iii) combination therapy arm: nightly sildenafil 50 mg (5 nights/week) plus intracavernosal injections twice/week. Inclusion criteria included bilateral nerve-sparing surgery, normal serum total testosterone, and good preoperative baseline erectile function as measured by the erectile function domain score of the IIEF (EFD) (≥24). Patients were followed with a medication use diary and the IIEF questionnaire at 6 weeks, 3 m, 6 m, 12 m, 18 m and 24 m. OUTCOMES: A difference was seen in the IIEF-EFD scores between the 3 groups at 24 months after RP. Secondary end points include the time to return of spontaneous functional erections, the time for patients to respond to oral erectogenic therapy, and the proportion of patients who have normalization of their IIEF-EFD scores. RESULTS: The study was interrupted because of failure to recruit the target study population in a reasonable timeframe. A total of 76 subjects with median age of 57 (IQR: 51, 63) years and mean IIEF-EFD of 29 (IQR: 27, 30) were initially randomized, but at 24 months, the sample sizes by group were (i) n = 4; (ii) n = 18; and (iii) n = 10, with median IIEF-EFD 24 (IQR: 18, 28), 24 (IQR: 18, 28), and 21 (IQR: 9, 26), respectively. There was no statistical difference among the groups in the final analysis. CLINICAL IMPLICATIONS: Definitive evidence for the ability of different pharmacological rehabilitation strategies to improve long-term EF outcomes might never be available. STRENGTHS & LIMITATIONS: This was a well-designed randomized and 3-arm designed trial intended to provide decisive evidence regarding the utility of penile rehabilitation. Failure to recruit the target population is the main limitation. CONCLUSION: The limited number of patients in the present trial precludes definitive interpretation. However, results indicate how challenging it is to conduct true rehabilitation studies. Miranda EP, Benfante N, Kunzel B, et al. A Randomized, Controlled, 3-Arm Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function After Radical Prostatectomy. J Sex Med 2021;18:423-429.

The Anatomical Relationships in the Space of Retzius for Penile Implants: An MRI Analysis.

BACKGROUND: The 3-piece inflatable penile prosthesis includes an easy-to-use pump and fluid filled reservoir which is placed in either the space of Retzius (SOR) or in an alternative ectopic location. Reservoir placement in the SOR is a blind procedure despite the SOR being surrounded by many critical structures. To date only a handful of cadaveric studies have described the relevant anatomy. AIM: To use magnetic resonance imaging (MRI) as an in-vivo model to study relevant retropubic anatomy critical for SOR reservoir placement. METHODS: The study population included men with elevated prostate specific antigen or biopsy proven prostate cancer who (i) underwent pelvic MRI, (ii) without prior pelvic or inguinal surgery, and (iii) without pelvic radiation therapy. All MRIs were completed with a 3-Tesla scanner and endorectal coil. Both T1 and T2 weighted images were captured in both axial and sagittal planes. All images were reviewed by 2 independent reviewers under the supervision of a dedicated body MRI radiologist. Bladder volume was calculated using an ellipsoid formula. OUTCOMES: Relevant measurements included (i) the distance between the external inguinal ring (EIR) at the level of the pubic tubercle to the external iliac vein (EIV), (ii) the distance from the EIR at the pubic tubercle to the bladder (accounting for bladder volume) and (iii) the distance from the midline pubic symphysis to the bladder (accounting for bladder volume). Pearson correlation was used to determine correlated measurements. RESULTS: A total of 24 patients were included. Median participant age was 63 years (interquartile range, 59-66). The mean EIR-EIV distance was 3.0 ± 0.4 cm, the mean EIR-bladder distance was 1.8 ± 1.0 cm and the mean distance from the superior pubic symphysis to bladder was 0.9 ± 0.3 cm. There was a weak correlation between bladder volume and distance between the EIR and bladder (r = -0.30, P = .16). CLINICAL IMPLICATIONS: The use of MRI as an in-vivo model is a high-fidelity tool to study real time unaltered anatomy and allows for surgical preparation, diagnosis of anatomic variants and acts as a valuable teaching tool. STRENGTHS & LIMITATIONS: This is the first in-vivo model to report relevant retropubic anatomy in penile implant surgery. Our study is limited by sample size and inclusion of participants with no history of prior pelvic intervention. CONCLUSION: We demonstrate the utility of MRI as an in-vivo model, as opposed to cadaveric models, for the understanding of relevant retropubic anatomy for implant surgeons. Punjani N, Monteiro L, Sullivan J F et al. The Anatomical Relationships in the Space of Retzius for Penile Implants: An MRI Analysis. J Sex Med 2021;18:1830-1834.

Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI).

BACKGROUND: No validated English language patient-reported outcome (PRO) currently exists that assesses satisfaction with inflatable penile prosthesis (IPP). Satisfaction data have been largely based primarily on surgeon assessment of patients or using questionnaires that have not been designed for this purpose. AIM: To develop an English-language validated PRO that assesses patient satisfaction after IPP surgery. METHODS: Initially, a literature review and discussions with experts defined domains important to IPP satisfaction (pain, appearance, function, overall satisfaction). The initial 35-item Satisfaction Survey for Inflatable Penile Implant (SSIPI) was developed. Cognitive interviews were then performed with IPP patients (n = 12) to gain feedback on the SSIPI domains and items. These data were used to modify SSIPI with the addition of 2 questions for a final item number of 37. Patients from 4 centers, who were between 6 months and 5 years after IPP, were administered the questionnaire through RedCap. Reliability statistics and content analysis were used to winnow questions to yield the final 16-item version of the SSIPI. Internal consistency was assessed via Cronbach's alpha and item-total correlation. Test-retest reliability was assessed via intraclass correlation coefficients using baseline and 2-week data. For convergent validity, the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship (SEAR) questionnaire were used. For discriminant validity, the International Prostate Symptom Score (IPSS) was used. Confirmatory factor analysis was used to assess the factor structure of the SSIPI. OUTCOMES: Internal consistency, test-retest reliability, convergent and discriminant validity, and confirmatory factor analysis were assessed. RESULTS: 118 men were surveyed. Mean age was 66.8 ± 9.5 years. The 16-item SSIPI showed high internal consistency with an overall Cronbach's Alpha of 0.97 (domains 0.85-0.89). Item-total correlations for individual items to subscales ranged from 0.60 to 0.91. The overall test-retest reliability was 0.94 (domains 0.87-0.93). Erectile Dysfunction Inventory of Treatment Satisfaction and Self-Esteem and Relationship had correlations of 0.84 overall (domains 0.57-0.79) and 0.47 overall (domains 0.34-0.44), respectively. International Prostate Symptom Score (discriminant validity) had correlations of -0.29 overall (domains -0.17 to -0.31). CLINICAL IMPLICATIONS: SSIPI is the first English-language validated IPP satisfaction PRO. This will enable clinicians to collect satisfaction data in a standardized way. STRENGTHS AND LIMITATIONS: As strengths we have used a rigorous psychometric process and have no industry sponsorship. Limitations include small numbers of specific subpopulations. CONCLUSION: The SSIPI has demonstrated robust psychometric properties. Salter CA, Bach PV, Jenkins L, et al. Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI). J Sex Med 2021;18:1641-1651.

Men's sexual help-seeking and care needs after radical prostatectomy or other non-hormonal, active prostate cancer treatments.

OBJECTIVE: To examine prostate cancer (PCa) survivors' sexual help-seeking intentions, behaviours, and unmet needs. METHODS: In this prospective cohort study, men who underwent active, non-hormonal treatment completed baseline (N = 558) and 6-month follow-up (N = 387) questionnaires. Theory of planned behaviour (TPB) constructs (sexual help-seeking intention, perceived behavioural control (PBC), subjective norm, attitude), masculine values (e.g., sexual importance/priority, emotional self-reliance), sex life and functioning, sexual supportive care needs, distress (anxiety, depression), and sexual help-seeking behaviour were assessed. RESULTS: Most men (M age = 64.6 years; M years post-diagnosis = 4.0) received prostatectomy (93%), reported severe erectile dysfunction (52%), ≥ 1 unmet sexual care need (66%), and sought help from a doctor (baseline 52%, follow-up 42%). Sexual care needs were significantly associated with poorer erectile function, reduced satisfaction with sex-life, valuing sex as important/integral to identity (masculine values), and increased depression (p ≤ 0.001). Sexual help-seeking intentions were significantly associated with valuing sex as important/integral to identity, recent help-seeking, greater confidence/control, perceiving support from important others, and positive attitudes, for sexual help-seeking (p < 0.001). Significant predictors of sexual help-seeking (follow-up) were baseline intentions, recent help-seeking (p < 0.001), and increased anxiety (p < 0.05). CONCLUSIONS: Men's unmet sexual care needs, sexual help-seeking intentions, and behaviour appear driven by the importance/value attributed to sex, distress, positive feelings, support from others, and confidence for help-seeking. Psychosocial providers are well-placed to address men's concerns, yet few sought their assistance. Interventions to improve men's access to effective sexual care are needed, particularly focused on reframing masculine values about the importance of sex and leveraging TPB-based predictors of help-seeking.

The Sickness Behavior Inventory-Revised: Sickness behavior and its associations with depression and inflammation in patients with metastatic lung cancer.

BACKGROUND: Inflammation may contribute to the high prevalence of depressive symptoms seen in lung cancer. "Sickness behavior" is a cluster of symptoms induced by inflammation that are similar but distinct from depressive symptoms. The Sickness Behavior Inventory-Revised (SBI-R) was developed to measure sickness behavior. We hypothesized that the SBI-R would demonstrate adequate psychometric properties in association with inflammation. METHOD: Participants with stage IV lung cancer (n = 92) were evaluated for sickness behavior using the SBI-R. Concomitant assessments were made of depression (Patient Hospital Questionniare-9, Hospital Anxiety and Depression Scale) and inflammation [C-reactive protein (CRP)]. Classical test theory (CTT) was applied and multivariate models were created to explain SBI-R associations with depression and inflammation. Factor Analysis was also used to identify the underlying factor structure of the hypothesized construct of sickness behavior. A longitudinal analysis was conducted for a subset of participants. RESULTS: The sample mean for the 12-item SBI-R was 8.3 (6.7) with a range from 0 to 33. The SBI-R demonstrated adequate internal consistency with a Cronbach's coefficient of 0.85, which did not increase by more than 0.01 with any single-item removal. This analysis examined factor loadings onto a single factor extracted using the principle components method. Eleven items had factor loadings that exceeded 0.40. SBI-R total scores were significantly correlated with depressive symptoms (r = 0.78, p < 0.001) and CRP (r = 0.47, p < 0.001). Multivariate analyses revealed that inflammation and depressive symptoms explained 67% of SBI-R variance. SIGNIFICANCE OF RESULTS: The SBI-R demonstrated adequate reliability and construct validity in this patient population with metastatic lung cancer. The observed findings suggest that the SBI-R can meaningfully capture the presence of sickness behavior and may facilitate a greater understanding of inflammatory depression.