NCT03328091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
662

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2020

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

October 25, 2017

Last Update Submit

January 17, 2024

Conditions

Prostate Cancer

Keywords

Prostate CancerGenetics

Outcome Measures

Primary Outcomes (1)

  • Prevalence of germline mutations in males with prostate cancer

    The proportion of participants who test positive for pathogenic or likely pathogenic variants

    2 years

Secondary Outcomes (7)

  • Genetic testing uptake

    2 years

  • Secondary or other primary (non-prostate) malignancies

    2 years

  • Genetic testing satisfaction score

    at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure

  • Multidimensional Impact of Cancer Risk Assessment score and subscales

    1 and 4 months post-result disclosure

  • Knowledge of multigene panel testing score

    4 months post-result disclosure

  • +2 more secondary outcomes

Study Arms (2)

Traditional pre-test genetic counseling

ACTIVE COMPARATOR

* 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.

Other: Traditional pre-test genetic counseling

Pre-test video education

EXPERIMENTAL

* 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

Other: Pre-test video education

Interventions

Traditional pre-test genetic counselingOTHER

Participant meets with a genetic counselor at the Center for Cancer Genetics and Prevention and traditional pre-test cancer genetic counseling is provided

Traditional pre-test genetic counseling
Pre-test video educationOTHER

The video is designed to mirror the educational components of a traditional genetic counseling visit

Pre-test video education

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • Rana 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: 37733980DERIVED

  • 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.

    PMID: 36103646DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Huma Q Rana, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 1, 2017

Study Start

November 21, 2017

Primary Completion

February 13, 2020

Study Completion

February 13, 2020

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)