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

Protocol # :
Prostate Cancer
Not Applicable
Disease Sites
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

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

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)