A randomized controlled trial of video-education or in-person genetic counseling for men with prostate cancer (ProGen).

Authors

null

Huma Q. Rana

Medical Oncology, Dana-Farber Cancer Institute, Boston, MA

Huma Q. Rana , Jill E. Stopfer , Nancie Petrucelli , Diane R. Koeller , Sara Pirzadeh-Miller , Brian Reys , Lindsay Kipnis , Samantha Culver , Donna Rachel Vatnick , Rebecca Silver , Joanna Mercado , Rebecca Sue Gelman , Michelle Weitz , Virginia Speare , Jill S. Dolinsky , Elisabeth I. Heath , Theodora Suzanne Ross , Kevin Dale Courtney , Judy Ellen Garber , Mary-Ellen Taplin

Organizations

Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Boston, MA, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, University of Texas Southwestern Medical Center, Dallas, TX, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA, Dana-Farber Cancer Institute, Boston, MA, Ambry Genetics, Aliso Viejo, CA

Research Funding

Other
2018 Medical Oncology Department Award

Background: Approximately 10% of men with advanced prostate cancer (PC) have pathogenic/likely pathogenic variants (PV) in cancer susceptibility genes and their identification may lead to targeted therapy. Genetic testing (GT) can also guide cancer surveillance and prevention for family members. While GT is recommended for men with potentially lethal PC, traditional testing models are strained, and access limited. The ProGen study examined a novel pretest model aimed at providing access to GT while promoting informed consent. Methods: Inclusion criteria were: potentially lethal PC (metastatic, localized with Gleason score ≥8, rising/persistent PSA after local therapy), diagnosis age ≤ 55 years, prior malignancy, family history suggestive of a PV and/or at oncologist’s discretion. Consented subjects from 3 sites were randomized 3:1 to video education (VE) or in-person genetic counseling (GC). Subjects who consented to GT had 67 genes analyzed (Ambry, USA) with results disclosed by telephone by a genetic counselor. Outcomes included GT uptake, PV prevalence, and survey measures of satisfaction, distress, genetics knowledge, family communication, and impact on cancer care (obtained at the time of intervention, and at 1, 4, and 12 months after result disclosure). Two-sided Fischer exact tests were used for between-arm comparisons. Results: Over a 2-year period: 662 subjects were randomized, VE or GC were completed by 604 subjects (VE: 93.1%, GC: 88.8%) of whom 596 subjects (VE:98.9%, GC:97.9%) consented to GT. To date, 591 subjects have completed GT (VE: 99.3%, GC: 98.6%). At the time of intervention, most subjects agreed or strongly agreed that their assigned arm was useful (VE: 95%, GC: 88%). Differences were not statistically significant. Notably, 84 PV were identified in 78 subjects (13.2%), with BRCA1/2 PV accounting for 32% of subjects with a positive result (BRCA2:21, BRCA1:4). Conclusions: In this randomized trial, both novel VE and traditional GC yielded high GT uptake without significant differences in outcome measures of acceptability and satisfaction. VE enabled access to critical GT results while maintaining the core tenants of informed consent. PV were found in 13.2% of subjects, 32% of whom had BRCA1/2 PV. Analysis of collected survey data to inform strengths and limitations of VE as compared with pretest GC will be presented. Clinical trial information: NCT03328091

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Oral Abstract Session

Session Title

Cancer Prevention, Risk Reduction, and Genetics

Track

Prevention, Risk Reduction, and Genetics

Sub Track

Cancer Genetics

Clinical Trial Registration Number

NCT03328091

Citation

J Clin Oncol 38: 2020 (suppl; abstr 1507)

DOI

10.1200/JCO.2020.38.15_suppl.1507

Abstract #

1507

Abstract Disclosures