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

Condition: Prostate Cancer

Intervention:

• Other: Traditional pre-test genetic counseling
• Other: Pre-test video education

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03328091

Sponsor: Dana-Farber Cancer Institute

Primary Outcome Measures:

• Measure: Prevalence of germline mutations in males with prostate cancer
• Time Frame: 2 years
• Safety Issue:

Secondary Outcome Measures:

• Measure: Genetic testing uptake
• Time Frame: 2 years
• Safety Issue:
• Measure: Secondary or other primary (non-prostate) malignancies
• Time Frame: 2 years
• Safety Issue:
• Measure: Genetic testing satisfaction score
• Time Frame: at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure
• Safety Issue:
• Measure: Multidimensional Impact of Cancer Risk Assessment score and subscales
• Time Frame: 1 and 4 months post-result disclosure
• Safety Issue:
• Measure: Knowledge of multigene panel testing score
• Time Frame: 4 months post-result disclosure
• Safety Issue:
• Measure: Family communication for those who tested positive for a genetic mutation
• Time Frame: 1 and 4 months post-result disclosure
• Safety Issue:
• Measure: Intent to disclose genetic test results
• Time Frame: pre-result disclosure
• Safety Issue:

Estimated Enrollment: 660

Study Start Date: November 21, 2017

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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)

Contact:

• Donna Rachel Vatnick
• Donna_Vatnick@DFCI.HARVARD.EDU
• 617-632-2077

Locations:

• Dana Farber Cancer Institute
• Boston Massachusetts 02115 United States

• Barbara Ann Karmanos Cancer Institute
• Detroit Michigan 48201 United States

• UT Southwestern Medical Center
• Dallas Texas 75390 United States

View trial on ClinicalTrials.gov