Pretest Video Education Versus Genetic Counseling for Patients With Prostate Cancer: ProGen, A Multisite Randomized Controlled Trial.

PURPOSE: Germline genetic testing (GT) is recommended for men with prostate cancer (PC), but testing through traditional models is limited. The ProGen study examined a novel model aimed at providing access to GT while promoting education and informed consent. METHODS: Men with potentially lethal PC (metastatic, localized with a Gleason score of ≥8, persistent prostate-specific antigen after local therapy), diagnosis age ≤55 years, previous malignancy, and family history suggestive of a pathogenic variant (PV) and/or at oncologist's discretion were randomly assigned 3:1 to video education (VE) or in-person genetic counseling (GC). Participants had 67 genes analyzed (Ambry), with results disclosed via telephone by a genetic counselor. Outcomes included GT consent, GT completion, PV prevalence, and survey measures of satisfaction, psychological impact, genetics knowledge, and family communication. Two-sided Fisher's exact tests were used for between-arm comparisons. RESULTS: Over a 2-year period, 662 participants at three sites were randomly assigned and pretest VE (n = 498) or GC (n = 164) was completed by 604 participants (VE, 93.1%; GC, 88.8%), of whom 596 participants (VE, 98.9%; GC, 97.9%) consented to GT and 591 participants completed GT (VE, 99.3%; GC, 98.6%). These differences were not statistically significant although subtle differences in satisfaction and psychological impact were. Notably, 84 PVs were identified in 78 participants (13.2%), with BRCA1/2 PV comprising 32% of participants with a positive result (BRCA2 n = 21, BRCA1 n = 4). CONCLUSION: Both VE and traditional GC yielded high GT uptake without significant differences in outcome measures of completion, GT uptake, genetics knowledge, and family communication. The increased demand for GT with limited genetics resources supports consideration of pretest VE for patients with PC.

A single institution experience with concurrent capecitabine and radiation therapy in weak and/or elderly patients with urothelial cancer.

PURPOSE: To describe a single institution experience in delivering concurrent capecitabine and radiation in elderly patients with urothelial cancer. METHODS AND MATERIALS: The records of patients with urothelial carcinoma treated with capecitabine and radiation at Wayne State University were reviewed. Capecitabine was administered at a median dose of 1600 mg/m2/day (range, 1200-1800 mg/m2). Concurrent radiation therapy (RT) of 40-45 Gy was delivered to a small pelvic field with a four-field technique, with additional boost to tumor area (total, 54-68.4 Gy). RESULTS: Fourteen patients who were not candidates for cystectomy or cisplatin-based therapy were treated with capecitabine and concurrent radiation therapy. Median age was 80 years (range, 46-88 years). Five patients had a performance status of 3. Nine patients had localized disease, and 5 patients had advanced disease. The most common overall toxicities were fatigue (43%), diarrhea (Grade 2, 14% and Grade 3, 29%), and dehydration (43%), with no Grade 4 or 5 toxicities. Of 14 patients, 3 (20%) required hospitalization for management of toxicities. Seven patients required dose modification, and the therapy was relatively well tolerated. Clinical complete response was seen in 11 of 13 evaluable patients (77%). At a median follow-up of 10.5 months, only 3 of 11 responders had relapsed. CONCLUSION: Concurrent capecitabine and radiation therapy is well-tolerated and demonstrates promising efficacy in urothelial carcinoma, thus offering a tolerable therapeutic option in elderly patients or those with impaired performance status.