Interventions that may reduce depressive symptoms among prostate cancer patients: a systematic review and meta-analysis.

OBJECTIVE: Prostate cancer patients are at increased risk of depression yet there is no standard intervention to address this. The purpose of this meta-analysis is to examine the efficacy of interventions in reducing depressive symptoms in men with prostate cancer. METHODS: Searches for studies were conducted in four databases and by hand. Randomized controlled trials of any intervention relative to control for depression in prostate cancer patients at any stage of their cancer treatment were included. RESULTS: We identified 11 studies that randomized men with prostate cancer to either an intervention meant to improve some aspect of quality of life or control and reported depressive symptoms scores before and after the intervention or control condition. Two of these were not used in our meta-analysis either for concerns about quality or for lack of depression scores. The interventions identified in the remaining nine articles were exercise (four), information (three), psychotherapy or peer support (three), massage therapy (one), and medication (one). Several publications included more than one type of intervention. A meta-analysis of all studies showed that an intervention of some types significantly improved depressive symptom scores relative to the control condition (improvement in depression score by -0.86 unit (95% CI: -1.42, -0.31)). Isolating the peer support/psychotherapy studies also showed significant improvement (improvement in depression score by -1.09 unit (95% CI: -2.05, -0.13)). CONCLUSION: Treatments to improve depressive symptoms in men with prostate cancer may be effective, with the best evidence supporting the use of peer support/psychotherapy.

Feasibility, acceptability and findings from a pilot randomized controlled intervention study on the impact of a book designed to inform patients about cancer clinical trials.

This study was conducted to assess the feasibility, acceptability, and changes in knowledge among cancer patients assigned to receive a 160-page book on experimental cancer therapies and clinical trials. We enrolled 20 patients with cancer who had never participated in a clinical trial and randomly assigned them to receive the book either during week 1 or week 4 of the study. We collected baseline patient demographic and cancer-related information as well as knowledge about cancer clinical trials at week 0. Follow-up surveys were administered at weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book early (at week 1) to those who received it later (at week 4). One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at week 3 and 95.5% in the Late Group at week 6). Within group pairwise comparisons found significant difference between baseline and week 6 in content-specific knowledge scores among participants in the Late Group [79% versus 92.1%, p = 0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials.

Phase II Study of Ipilimumab in Men With Metastatic Prostate Cancer With an Incomplete Response to Androgen Deprivation Therapy.

Background: Phase 3 studies of immune checkpoint inhibitors have not shown a survival benefit in prostate cancer, but some patients have a profound anticancer response. Patients and Methods: We evaluated the efficacy of the CTLA-4 targeted agent, ipilimumab, in metastatic prostate cancer patients who had an incomplete biochemical response to initial androgen deprivation therapy (ADT) alone. Ten patients were enrolled, each treated with ipilimumab 10 mg/kg (every 3 weeks for up to 4 doses) with maintenance ipilimumab every 12 weeks for non-progressing patients. The primary endpoint was proportion of patients with an undetectable PSA. The total sample size was 30 patients, but there was an interim analysis planned at 10 for futility. If none of the 10 patients achieved an undetectable PSA, the study would be halted. Results: The study was halted at the interim analysis as none of the 10 patients achieved the primary endpoint, but 30% of patients demonstrated a >50% reduction in PSA, with one patient achieving a >90% reduction in PSA. Peripheral blood mononuclear cells (PBMC) examined by mass cytometry showed that patients with clinical responses had an increase in effector memory T-cell subsets as well as an increase in T-cell expression of T-bet, suggesting induction of a Th1 response. Conclusions: This study provides further evidence that ipilimumab has activity in some patients with prostate cancer and provides further rationale for the development of future studies aimed at identifying a subset of patients with CPRC that are more likely to derive a benefit from treatment with ipilimumab. Implications for Practice: There is insufficient evidence to use ipilimumab in prostate cancer in routine practice. Trial Registration: ClinicalTrials.gov, NCT01498978. Registered 26 December 2011. https://www.clinicaltrials.gov/ct2/show/NCT01498978?term=julie+graff&rank=3.