Experiences of Men With Prostate Cancer Participating in a Clinical Pathway With a Supervised Group-based Exercise Program to Combat Androgen Deprivation-Induced Side Effects: A Qualitative Focus Group Study.

OBJECTIVES: A clinical pathway in daily practice improved implementation of evidence-based strategies for the management of androgen deprivation-induced side effects in men with prostate cancer. This study aimed to explore patients' expectations and reasons to start with the clinical pathway; explore patients' experiences and attitudes toward the pathway; and identify key pathway ingredients and examine patients' attitudes about a possible transition toward the home environment after a hospital-based pathway participation. DATA SOURCES: Focus group interviews were conducted through purposeful sampling, consisting of former and current participants of the clinical pathway at Ghent University Hospital. Data was audiotaped and transcribed verbatim, coded in NVivo12, and thematically and inductively analyzed through constant comparisons. CONCLUSION: Men with prostate cancer have positive experiences toward the use of a holistic multidisciplinary approach (ie, clinical pathway) to combat androgen deprivation therapy-induced side effects in practice. Patients identified several key ingredients of the pathway, such as peer support, physiotherapist involvement, and availability of a multidisciplinary team. Patients were, however, reluctant to continue the exercise component at home because of negative attitudes toward a public gym, practical issues, absence of known facilitators, and other priorities. IMPLICATIONS FOR NURSING PRACTICE: Referral by a health care provider remains an important motivator for pathway participation. Peer support, physiotherapist involvement, and availability of a multidisciplinary team are crucial components of the clinical pathway and should be taken into account when developing and implementing similar pathways to increase program uptake in daily practice.

Hyperbaric oxygen therapy for radiation cystitis after pelvic radiotherapy: Systematic review of the recent literature.

The present study assessed the efficacy of hyperbaric oxygen therapy in reducing symptoms of radiation cystitis, a specific type of iatrogenic injury to the bladder, by systematic review of recent literature. The MEDLINE, Embase and Web of Science databases were searched using combinations of the terms "radiation," "cystitis" and "hyperbaric oxygen" to identify articles evaluating patients with radiation cystitis, treated with hyperbaric oxygen therapy. Only recent (≤10 years) original studies were included. Data were extracted and pooled in order to calculate descriptive weighted averages. Articles were evaluated on their level of evidence. A total of 20 papers were obtained, resulting in a cohort of 815 patients who were treated with hyperbaric oxygen therapy for radiation cystitis. Overall and complete response rates varied from 64.8% to 100% and 20% to 100%, respectively. The weighted average overall and complete response rates were 87.3% and 65.3%, respectively. Adverse events were observed in 9.6% of the patients, but permanent side-effects were rare. The most prominent limitations were high cost and low availability. Hyperbaric oxygen therapy is effective in the treatment of radiation-induced cystitis, with minimal adverse events, but low availability and high cost. At present, evidence is low; therefore, more prospective studies are required.

Salvage Lymph Node Dissection for Nodal Recurrent Prostate Cancer: A Systematic Review.

CONTEXT: Identification of early nodal recurrence after primary prostate cancer (PCa) treatment by functional imaging may guide metastasis-directed therapy such as salvage lymph node dissection (SLND). OBJECTIVE: The aim of this systematic review was to assess the oncological role and the safety of SLND in the era of modern imaging in case of exclusive nodal recurrence after primary PCa treatment with curative intent. EVIDENCE ACQUISITION: A systematic literature search in the PubMed and Cochrane databases was performed up to August 2018 according to Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. Overall, 27 SLND series have been selected for synthesis. EVIDENCE SYNTHESIS: Prostate-specific membrane antigen or choline positron emission tomography/computed tomography was the reference detection technique. SLND was performed by open or laparoscopic approach with <10% of grade 3 or more complication rate. Mean follow-up was 29.4 mo. Complete biochemical response after SLND was achieved in 13-79.5%of cases (mean 44.3%). The 2- and 5-yr biochemical progression-free survival rates ranged from 23% to 64% and from 6% to 31%, respectively. Fiver-year overall survival was approximately 84%. Main drawbacks limiting the interpretation of the effectiveness of SLND were the retrospective design of single-center series, heterogeneity between series in terms of adjuvant treatment, endpoints, definitions of progression and study population, as well as the absence of long-term follow-up. CONCLUSIONS: A growing body of accumulated data suggests that SLND is a safe metastasis-directed therapy option in nodal recurrence after primary treatment. However, to date, high level of evidence is still missing to draw any clinically meaningful conclusion about the oncological impact of SLND on long-term endpoints. PATIENT SUMMARY: When imaging identifies exclusive nodal recurrent prostate cancer, surgery directed to the positive lesions is safe and can offer at least a temporary biochemical response. The oncological role assessed by strong clinical endpoints remains uncertain.

Are clinical guidelines designed according to guidelines? Cross-sectional assessment of quality and transparency of clinical guidelines in urology.

PURPOSE: Guidelines and recommendations become increasingly important in clinical urologic practice. This study aims to inform clinicians using guidelines on how to evaluate the quality of the methodology and transparency of these documents. METHODS: The guidelines on management of castration-resistant prostate cancer of the American Urology Association, European Association of Urology, National Comprehensive Cancer Network, National Institute for Health and Care Excellence, European Society of Medical Oncology were reviewed using the AGREE-II tool (Appraisal of Guidelines for Research and Evaluation). We reported and compared the domain scores for the domains 1 scope and purpose, 2 stakeholder involvement, 3 rigor of development, 4 clarity of presentation, 5 applicability, and 6 editorial independence (100% indicates highest-best quality score). RESULTS: The domains evaluated highest and with lowest variability were 'editorial independence' (92% {88-95%}) and 'clarity of presentation' (83% {72-90%}), while the domains with the lowest scores and most variability were 'stakeholder involvement' (56% {36-79%}) and 'applicability' (40% {30-63%}). Length and extent of detail of guidelines vary considerably, each with its own strengths and limitations and adapted to target users. Standard external review using AGREE criteria may be preferable. A formal search strategy was not performed. Findings may be outdated by guidelines' updates. CONCLUSIONS: Clinicians using practice guidelines need to be aware of the different domains of methodology and transparency used to assess the quality of guidelines contents and recommendations. Urologists increasingly use guidelines for support in evidence-based recommendations in clinical practice. It is very important to know how to assess these documents. This study applies standard criteria to compare the design and background of different available guidelines on prostate cancer no longer responding to hormonal treatment.

4 Weeks Versus 5 Weeks of Hypofractionated High-dose Radiation Therapy as Primary Therapy for Prostate Cancer: Interim Safety Analysis of a Randomized Phase 3 Trial.

PURPOSE: Hypofractionated radiation therapy (HFRT) for localized prostate cancer is safe and effective. The question that remains is which hypofractionation schedule to implement. We compared 2 different HFRT regimens in the present study. METHODS AND MATERIALS: From June 2013 to July 2016, 160 patients with prostate cancer were randomly assigned (1:1), within this single-center phase III trial, to 56 Gy (16 fractions of 3.5 Gy; arm A) or 67 Gy (25 fractions of 2.68 Gy; arm B). Randomization was performed using computer-generated permuted blocks, stratified by previous transurethral resection of the prostate and the presence of a dominant intraprostatic lesion. Treatment allocation was not masked, and the clinicians were not blinded. The primary endpoint was acute gastrointestinal (GI) toxicity, assessed using the Common Terminology Criteria for Adverse Events, version 4.0, and Radiation Therapy Oncology Group toxicity scale. An interim analysis of acute toxicity was planned at 160 patients to prove the safety of both treatment regimens. If ≥22 of 72 patients had grade ≥2 GI toxicity, the study arm would be rejected. The study is registered at ClinicalTrials.gov (NCT01921803). RESULTS: In arm A, 20 patients (26%) and 1 patient (1%) developed acute grade 2 and grade 3 GI toxicity. In arm B, 16 patients (20%) reported acute grade 2 GI toxicity. In arm A, 42 (55%) and 5 (6%) patients developed acute grade 2 and grade 3 urinary toxicity. In arm B, 40 (49%) and 7 (9%) patients reported acute grade 2 and grade 3 urinary toxicity. Toxicity peaked during radiation therapy and resolved in the months after radiation therapy. CONCLUSIONS: With acute grade ≥2 GI toxicity reported in 21 of 77 patients in arm A and 16 of 82 patients in arm B, both treatment arms can be considered safe.

Management of Node Only Recurrence after Primary Local Treatment for Prostate Cancer: A Systematic Review of the Literature.

PURPOSE: We analyzed all available studies assessing the management of node only recurrence after primary local treatment of prostate cancer. MATERIALS AND METHODS: We systematically reviewed the literature in January 2015 using the PubMed, Web of Sciences and Embase databases according to PRISMA guidelines. Studies exclusively reporting visceral or bone metastatic disease were excluded from analysis. Eight radiotherapy and 12 salvage lymph node dissection series were included in our qualitative study. RESULTS: All 248 radiotherapy and 480 salvage lymph node dissection studies were single arm case series including a total of 728 patients. Choline positron emission tomography/computerized tomography was the reference imaging technique for nodal recurrence detection. Globally 50% of patients remained disease-free after short-term followup. Nevertheless, approximately two-thirds of patients received adjuvant hormone therapy, leading an overestimation of prostate specific antigen-free survival rates obtained after salvage treatment. Combining radiotherapy with salvage lymph node dissection may improve oncologic control in the treated region without improving the outfield relapse risk or the prostate specific antigen response. Great heterogeneity among series in adjuvant treatments, endpoints, progression definitions and study populations made it difficult to assess the precise impact of salvage treatment on the prostate specific antigen response and compare outcomes between radiotherapy and salvage lymph node dissection series. Toxicity after radiotherapy or salvage lymph node dissection was acceptable without frequent high grade complications. The benefit of early hormone therapy as the only salvage treatment remains unknown. CONCLUSIONS: Although a high level of evidence is currently missing to draw any strong conclusion, published clinical series show that in select patients salvage treatment directed to nodal recurrence could lead to good oncologic outcomes. Although the optimal timing of androgen deprivation therapy in this setting is still unknown, such an approach could delay time to systemic treatment with an acceptable safety profile. Future prospective trials are awaited to better clarify this potential impact on well-defined endpoints.

Surveillance or metastasis-directed Therapy for OligoMetastatic Prostate cancer recurrence (STOMP): study protocol for a randomized phase II trial.

BACKGROUND: Metastases-directed therapy (MDT) with surgery or stereotactic body radiotherapy (SBRT) is emerging as a new treatment option for prostate cancer (PCa) patients with a limited number of metastases (≤3) at recurrence - so called "oligometastases". One of the goals of this approach is to delay the start of palliative androgen deprivation therapy (ADT), with its negative impact on quality of life. However, the lack of a control group, selection bias and the use of adjuvant androgen deprivation therapy prevent strong conclusions from published studies.The aim of this multicenter randomized phase II trial is to assess the impact of MTD on the start of palliative ADT compared to patients undergoing active surveillance. METHODS/DESIGN: Patients with an oligometastatic recurrence, diagnosed on choline PET/CT after local treatment with curative intent, will be randomised in a 1:1 ratio between arm A: active surveillance only and arm B: MTD followed by active surveillance. Patients will be stratified according to the location of metastasis (node vs. bone metastases) and PSA doubling time (≤3 vs. > 3 months). Both surgery and SBRT are allowed as MDT. Active surveillance means 3-monthly PSA testing and re-imaging at PSA progression. The primary endpoint is ADT-free survival. ADT will be started in both arms at time of polymetastatic disease (>3 metastatic lesions), local progression or symptoms. The secondary endpoints include progression-free survival, quality of life, toxicity and prostate-cancer specific survival. DISCUSSION: This is the first randomized phase 2 trial assessing the possibility of deferring palliative ADT with MDT in oligometastatic PCa recurrence. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01558427.

Evaluation of the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation.

The purpose of this pilot study was to evaluate the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation therapy (ADT). Ten patients experiencing hot flashes were included in a single-centre prospective pilot study. Treatment consisted of 150 mg of Salvia officinalis extract taken orally three times daily. A diary questionnaire scoring hot flashes, subjective side effects and quality of life (QOL) had to be completed. Clinical examination was performed at every visit and the concentration of ADT-linked hormones, haemoglobin and cholesterol was measured before, during and after ending treatment. Before the start of treatment, a 1 week baseline registration was performed. An analysis of variance with time of measurement as a within-subject factor was performed. When analysing the hot flashes score, one patient was excluded due to insufficient diary notes. The mean weekly score declined from 112 (SD = 71) at baseline to 59 (SD = 54) at the end of treatment (p = 0.002). Hot flashes diminished significantly from the first week up to and including week 3. This was maintained during treatment. There was no effect on QOL. There were no side effects. It is concluded that Salvia officinalis is efficient and safe in the treatment hot flashes, without improving QOL.