A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for Locally Advanced Prostate Cancer.

PURPOSE: Men with locally advanced prostate cancer who undergo radical prostatectomy (RP) often develop recurrence and require postoperative radiotherapy. We aimed to determine the safety of neoadjuvant stereotactic body radiotherapy (SBRT) before RP in this population. METHODS AND PATIENTS: A single-institution phase 1 trial (NCT02946008) of men with high-risk or node-positive prostate cancer were enrolled between March and October 2017. The primary endpoint was to determine the maximum tolerated dose of SBRT based on a composite 30-day post-RP toxicity goal of ≤28% of patients experiencing a dose-limiting toxicity (DLT). Secondary outcomes included toxicity, efficacy, and multiple quality of life (QoL) inventories. SBRT (30-35 Gy/5 fractions) was delivered to the prostate and seminal vesicles, and 25 Gy/5 fractions to the pelvic lymph nodes. RP was performed for a median of 6 weeks post-SBRT. Hormone therapy was not allowed. RESULTS: Median follow-up was 40 months (range, 33-44). Twenty-five percent of the patients (n = 4) experienced a DLT within 30 days post-RP; however, the trial was stopped early (n = 16 of planned 38 patients) owing to the proportion and severity of the late adverse events. Post-RP grade 3 genitourinary and gastrointestinal toxicities occurred in 75% (n = 12) and 25% (n = 4) of patients, respectively. Two patients required cystectomy and urinary diversion ≥2 years post-RP. At 24 months post-RP, 75% (n = 12) of men used ≥1 pad/d and 0% had erections suitable for intercourse. Surgical margins were negative in all patients and 31% (n = 5) had complete or partial (pre-RP) MRI-response to SBRT. Three-year biochemical recurrence and distant metastasis were 45% (95% CI, 5%-68%) and 28% (95% CI, 0%-49%), respectively. CONCLUSIONS: Neoadjuvant SBRT followed by RP resulted in unacceptably high toxicity and severe QoL declines.

Five-year outcomes from a randomised controlled trial of a couples-based intervention for men with localised prostate cancer.

OBJECTIVE: Psychosexual morbidity is common after prostate cancer treatment, however, long-term prospective research is limited. We report 5-year outcomes from a couples-based intervention in dyads with men treated for localised prostate cancer with surgery. METHODS: A randomised controlled trial was conducted involving 189 heterosexual couples, where the man received a radical prostatectomy for prostate cancer. The trial groups were peer support vs. nurse counselling versus usual care. Primary outcomes were sexual adjustment, unmet sexual supportive care needs, masculine self-esteem, marital satisfaction, and utilisation of erectile aids at 2-, 3-, 4- and 5-year follow-up. RESULTS: The effects of the interventions varied across the primary outcomes. Partners in the peer group had higher sexual adjustment than those in the usual care and nurses group at 2 and 3 years (P = 0.002-0.035). Men in usual care had lower unmet sexual supportive care needs than men in the peer and nurse groups (P = 0.001; P = 0.01) at 3 years. Women in usual care had lower sexual supportive care needs than women in the peer group at 2 and 3 years (P = 0.038; P = 0.001). Men in the peer and nurse group utilised sexual aids more than men in usual care; at 5 years 54% of usual care men versus 87% of men in peer support and 80% of men in the nurse group. CONCLUSION: Peer and nurse-administered psychosexual interventions have potential for increasing men's adherence to treatments for erectile dysfunction. Optimal effects may be achieved through an integrated approach applying these modes of support.

Symptom burden and information needs in prostate cancer survivors: a case for tailored long-term survivorship care.

OBJECTIVES: To determine the relationship between long-term prostate cancer survivors' symptom burden and information needs. PATIENTS AND METHODS: We used population-based data from the Michigan Prostate Cancer Survivor Study (2499 men). We examined unadjusted differences in long-term information needs according to symptom burden and performed multivariable logistic regression to examine symptom burden and information needs adjusting for patient characteristics. RESULTS: High symptom burden was reported across all domains (sexual 44.4%, urinary 14.4%, vitality 12.7%, bowel 8.4%, emotional 7.6%) with over half of respondents (56%) reporting they needed more information. Top information needs involved recurrence, relationships, and long-term effects. Prostate cancer survivors with high symptom burden more often searched for information regardless of domain (P < 0.05). High sexual burden was associated with greater need for information about relationships [odds ratio (OR) 2.05, 95% confidence interval (CI) 1.54-2.72] and long-term effects (OR 1.60, 95% CI 1.23-2.07). High bowel burden was associated with greater information need for long-term effects (OR 2.28, 95% CI 1.43-3.63). CONCLUSIONS: Long-term prostate cancer survivors with high symptom burden need more supportive information. Tailoring information to these needs may be an efficient approach to support the growing population of long-term prostate cancer survivors.

Expanding the NCCN guidelines for distress management: a model of barriers to the use of coping resources.

Cancer-related distress impacts quality of care, resource use, and patient outcomes. Patients are increasingly screened for distress, yet many do not receive coping resources and psychosocial support services that may help to reduce their distress. Distress screening must be paired with attention to the different phases of the distress and coping process, with emphasis on barriers and facilitators of cancer patients' use of coping resources. This paper offers a conceptual model illustrating key pathways and modifying factors of distress and use of coping resources among cancer patients, and potential roles for cancer care providers and institutions in facilitating effective coping and distress reduction. Building on a review of relevant empirical and theoretical literature, we developed a conceptual model that integrates concepts from Stress and Coping Theory into the National Comprehensive Cancer Network's guidelines for Distress Management. We found that barriers and facilitating factors that may inhibit receipt of coping resources and services to reduce cancer-related distress include health and cancer beliefs, accessibility and acceptability, the role of caregivers in cancer treatment, coordination of care, and the quality of patient-provider relationships. Herein, we highlight largely modifable factors that can infuence the successful uptake of coping resources and services to reduce distress among cancer patients. We conclude with recommendations for how cancer care providers and systems can better identify and address barriers to the use of distress reduction resources and support services.