Clinical trial · Interventional
Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)
NCT03328091CI-TRIAL-00073100ProGencompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-test video education | Other | — | UNRESOLVED |
| Traditional pre-test genetic counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Traditional pre-test genetic counseling
- 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.
- interventionNames
- Other: Traditional pre-test genetic counseling
- type
- EXPERIMENTAL
- label
- Pre-test video education
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (2)
- DERIVEDRana HQ, Stopfer JE, Weitz M, Kipnis L, Koeller DR, Culver S, Mercado J, Gelman RS, Underhill-Blazey M, McGregor BA, Sweeney CJ, Petrucelli N, Kokenakes C, Pirzadeh-Miller S, Reys B, Frazier A, Knechtl A, Fateh S, Vatnick DR, Silver R, Kilbridge KE, Pomerantz MM, Wei XX, Choudhury AD, Sonpavde GP, Kozyreva O, Lathan C, Horton C, Dolinsky JS, Heath EI, Ross TS, Courtney KD, Garber JE, Taplin ME. Pretest Video Education Versus Genetic Counseling for Patients With Prostate Cancer: ProGen, A Multisite Randomized Controlled Trial. JCO Oncol Pract. 2023 Nov;19(11):1069-1079. doi: 10.1200/OP.23.00007. Epub 2023 Sep 21. PMID 37733980
- DERIVEDBerchuck 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. PMID 36103646