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

Condition: Prostate Cancer


  • 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


  • 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)


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


  • 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