Prostate Cancer Clinical Trial
Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)
Summary
This randomized controlled trial aims to evaluate the impact of pre-test video education and post-test genetic counseling as compared to in-person pre-test genetic counseling in males with advanced prostate cancer.
Full Description
Participants will be randomized to either pre-test video education and post-test genetic counseling or in-person pre-test genetic counseling. Outcomes evaluated are: prevalence of germline mutations, uptake of genetic testing, satisfaction with testing, knowledge of multi-gene panels, distress, result disclosure to relatives, and the impact on personal or family medical care. Through this study, the investigators will learn about the inherited causes of prostate cancer, and how and when genetic testing should be offered to this population.
Eligibility Criteria
Inclusion Criteria:
Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)
Localized prostate cancer with Gleason score ≥8
Rising PSA after prostatectomy or radiation with PSA doubling time ≤ 6 months
Persistent PSA after prostatectomy for PSA ≥ 0.2 ng/mL observed in testing at least 1 week apart
Prostate cancer diagnosed at age ≤ 55 years
Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer.
Prostate cancer diagnosis (any grade/stage) or prostate biopsy with high grade PIN or small acinar proliferation and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age ≤ 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives)
Exclusion Criteria:
Previous cancer genetic testing or counseling, or prior germline multigene panel testing. Previous tumor sequencing is acceptable if no genetic counseling took place.
Localized prostate cancer previously treated and in remission for > 2 years unless family history potentially indicates a germline mutation.
Active hematologic malignancy (e.g. CLL)
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There are 3 Locations for this study
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Dallas Texas, 75390, United States
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