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Genetic Counseling Processes and Outcomes Among Males with Prostate Cancer (ProGen)

Not Enrolling

Trial ID:NCT03328091

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Protocol #:17-409

877-DF-TRIAL (877-338-7425)

Condition(s):Prostate Cancer

Phase:Not Applicable

Principal Investigator:Rana, Huma

Trial Description:
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.

Eligibility Requirements:
- 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)

Protocol #: 17-409

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