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

Dana-Farber Cancer Institute

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Pre-test video education; Other: Traditional pre-test genetic counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03328091

17-409

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 662 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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662 participants in 2 patient groups

Traditional pre-test genetic counseling

Active Comparator group

Description:

* In-person consultation with licensed genetic counselor at the Center for Cancer Genetics and Prevention before genetic testing * Participant is given a pamphlet introducing prostate cancer genes, genetic testing * Participant is sent electronic family history tool * Participant is given the "Genetic Testing Information for Decision Making" packet. After the genetic counseling session, patient is asked if they would like to proceed with genetic testing.

Treatment:

Other: Traditional pre-test genetic counseling

Pre-test video education

Experimental group

Description:

* Participant is given a pamphlet that describes the basics of prostate cancer genes, genetic testing * Participant is sent electronic family history tool * Participant is approached in clinic by research staff at a pre-planned time * The patient is given the "Genetic Testing Information for Decision Making" packet * The pre-test video education is a short video. Information will be provided about the basics of genetics and mutations, the potential benefits, risks, and limitations of genetic testing, and the possible results the participant may receive

Treatment:

Other: Pre-test video education