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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:November 21, 2017
End Date:November 30, 2023
Contact:Donna Rachel Vatnick
Email:Donna_Vatnick@DFCI.HARVARD.EDU
Phone:617-632-2077

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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.

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.

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

- 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.

- Localized prostate cancer previously treated and in remission for > 2 years unless
family history potentially indicates a germline mutation.
We found this trial at
1
site
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Huma Q Rana, MD
Phone: 617-632-2077
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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