Status:
COMPLETED
Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
University of Texas Southwestern Medical Center
Barbara Ann Karmanos Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 pr...
Detailed 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, ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2020
Estimated Enrollment :
662 Patients enrolled
Trial Details
Trial ID
NCT03328091
Start Date
November 21 2017
End Date
February 13 2020
Last Update
January 18 2024
Active Locations (3)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
3
UT Southwestern Medical Center
Dallas, Texas, United States, 75390