Improving bone health in men with prostate cancer receiving androgen deprivation therapy: Results of a randomized phase 2 trial.

BACKGROUND: Strategies to improve bone health care in men receiving androgen deprivation therapy (ADT) are not consistently implemented. The authors conducted a phase 2 randomized controlled trial of 2 education-based models-of-care interventions to determine their feasibility and ability to improve bone health care. METHODS: A single-center parallel-group randomized controlled trial of men with prostate cancer who were receiving ADT was performed. Participants were randomized 1:1:1 to 1) a patient bone health pamphlet and brief recommendations for their family physician (BHP+FP); 2) a BHP and support from a bone health care coordinator (BHP+BHCC); or 3) usual care. The primary efficacy outcome was receipt of a bone mineral density (BMD) test within 6 months. Secondary efficacy outcomes included guideline-appropriate calcium and vitamin D use and bisphosphonate prescriptions for men at high fracture risk. Feasibility endpoints included recruitment, retention, satisfaction, contamination, and outcome capture. The main analysis used logistic regression with a 1-sided P of .10. The trial is registered at ClinicalTrials.gov (identifier NCT02043236). RESULTS: A total of 119 men were recruited. The BHP+BHCC strategy was associated with a greater percentage of men undergoing a BMD test compared with the usual-care group (78% vs 36%; P<.001). BMD ordering also was found to be increased with the BHP+FP strategy (58% vs 36%; P = .047). Both strategies were associated with higher percentages of patients using calcium and vitamin D, but only the BHP+FP arm was statistically significant (P = .039). No men were detected to be at high fracture risk. All but one feasibility endpoint was met. CONCLUSIONS: Educational strategies to improve bone health care appear feasible and are associated with improved BMD ordering in men receiving ADT. Cancer 2018;124:1132-40. © 2017 American Cancer Society.

A comparison of the CARG tool, the VES-13, and oncologist judgment in predicting grade 3+ toxicities in men undergoing chemotherapy for metastatic prostate cancer.

OBJECTIVE: Since the benefits of chemotherapy in treating older men with metastatic castration-resistant prostate cancer (mCRPC) are modest, validated tools that predict the risk of treatment toxicity may aid clinical decision-making. Whether these tools are better than oncologist judgment remains unclear. We compared the Cancer and Aging Research Group (CARG) tool, the Vulnerable Elders Survey-13 (VES-13), and oncologist judgment in predicting toxicity in men with mCRPC undergoing chemotherapy. MATERIALS AND METHODS: Men aged 65+ with mCRPC starting first-line or second-line chemotherapy were enrolled in this prospective observational study. At baseline, VES-13 and CARG risk scores were calculated and treating oncologists were asked to rate toxicity risk on a 10-point scale. Toxicity was captured using the Common Terminology Criteria for Adverse Events version 4. Logistic regression was performed to examine relationships between risk prediction tools and the development of grade 3+ toxicity. RESULTS: 46 patients (mean age 75) were accrued, with most receiving Docetaxel 75mg/m2 q3weekly. A total of 9 patients (20%, 95% confidence interval (CI) 9-34%) developed grade 3+ toxicity. Using the CARG tool, 0% (95% CI 0-84%), 17% (95% CI 6-36%), and 27% (95% CI 18-55%) of patients in the low, intermediate, and high risk groups developed grade 3+ toxicity, respectively (p=0.65). Although the CARG tool, the VES-13, and oncologist judgment appeared to perform similarly, comparisons were limited by the small sample size. CONCLUSION: Chemotherapy for mCRPC was associated with lower than predicted rates of severe toxicity across all predicted risk groups. Further disease-specific validation studies are warranted.

A prospective study examining elder-relevant outcomes in older adults with prostate cancer undergoing treatment with chemotherapy or abiraterone.

BACKGROUND: Treatment of metastatic castration-resistant prostate cancer (mCRPC) with chemotherapy improves disease control and survival in fit older men (age 65+) but its impact on function is not clear. We hypothesized that chemotherapy would impair daily function in older men with mCRPC. METHODS: Men aged 65+ with mCRPC starting chemotherapy or abiraterone were enrolled in this prospective observational pilot study. Daily function was evaluated with the OARS Instrumental Activities of Daily Living (IADL) scale. Three objective measures were used to assess physical function. Patients completed Functional Assessment of Cancer Therapy questionnaires measuring prostate-specific and general quality-of-life (QOL). Vulnerability was evaluated using the Vulnerable Elders Survey (VES-13). Assessments were completed before each cycle of chemotherapy or every 2-3 months for those receiving abiraterone. We compared outcomes pre- and post-treatment and with published minimal clinically important differences. RESULTS: We evaluated 29 and 7 men on 1st-line and 2nd-line chemotherapy (median 6 and 7 cycles, respectively) and 11 men receiving abiraterone for a median 7 months. IADL scores declined slightly after 1st-line chemotherapy (mean -0.31 points, 95% confidence interval 0.39, -1.02). Physical performance remained stable over time. Both general and prostate-specific QOL improved with 1st-line chemotherapy. For all but one outcome (Timed Chair Stands), vulnerable men had similar changes over time compared to non-vulnerable men. Second-line chemotherapy and abiraterone were generally well-tolerated. CONCLUSION: IADL function declined slightly whereas physical function remained stable and QOL improved during chemotherapy. Vulnerable and non-vulnerable older men with mCRPC appear to tolerate 1st-line chemotherapy fairly well.