Clinical trial NCT03328091: Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)
Official title: Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Genetics
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Barbara Ann Karmanos Cancer Institute
First posted: 2017-11-01
Enrollment: 662
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 prostate cancer.

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, 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prevalence of germline mutations in males with prostate cancer
timeFrame: 2 years
Secondary outcomes:
measure: Genetic testing uptake
timeFrame: 2 years
measure: Secondary or other primary (non-prostate) malignancies
timeFrame: 2 years
measure: Genetic testing satisfaction score
timeFrame: at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure
measure: Multidimensional Impact of Cancer Risk Assessment score and subscales
timeFrame: 1 and 4 months post-result disclosure
measure: Knowledge of multigene panel testing score
timeFrame: 4 months post-result disclosure
measure: Family communication for those who tested positive for a genetic mutation
timeFrame: 1 and 4 months post-result disclosure
measure: Intent to disclose genetic test results
timeFrame: pre-result disclosure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Huma Q Rana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berchuck JE, Boiarsky D, Silver R, Sunkara R, McClure HM, Tsai HK, Siegmund S, Tewari AK, Nowak JA, Lindeman NI, Rana HQ, Choudhury AD, Pomerantz MM, Freedman ML, Van Allen EM, Taplin ME. Addition of Germline Testing to Tumor-Only Sequencing Improves Detection of Pathogenic Germline Variants in Men With Advanced Prostate Cancer. JCO Precis Oncol. 2022 Aug;6:e2200329. doi: 10.1200/PO.22.00329.