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AzTrials

Prostate CancerProGenNCT03328091

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

A study testing Traditional pre-test genetic counseling and Pre-test video education in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Traditional pre-test genetic counseling and Pre-test video education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
662 participants
Where
3 sitesUnited States
Study dates
21 Nov 2017to 13 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

United States3 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Traditional pre-test genetic counseling, Pre-test video education
Keywords
Prostate Cancer, Genetics
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Pre-test video educationOther

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

Study groups in NCT03328091
Study groupRoleWhat they receive
Traditional pre-test genetic counselingActive 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.
Receives: Other: Traditional pre-test genetic counseling
Pre-test video educationExperimental* 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
Receives: Other: Pre-test video education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of germline mutations in males with prostate cancer

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

    Measured: 2 years

Secondary outcomes (7)

  1. Genetic testing uptake

    The proportion of participants who consent to genetic testing in the pre-test video education arm

    Measured: 2 years

  2. Secondary or other primary (non-prostate) malignancies

    Assessed by chart review. Participants with positive genetic test results will fill out the "Positive Test Results" Survey to report any additional cancer diagnoses.

    Measured: 2 years

  3. Genetic testing satisfaction score

    A validated survey of participants' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly". At the time of 1 month post-result disclosure, an additional set of 5 questions will be added. Four of these five questions will be evaluated using the previously described parameters. The remaining question will be answered by the response options: "yes", "no", or "I did not get the packet". Survey responses will be re-coded on a numerical scale consistent with the standard Likert scale.

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

  4. Multidimensional Impact of Cancer Risk Assessment score and subscales

    MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer. Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale. Section 2 contains two items for participants who have children. Section 3 contains 2 items for participants who have/have had cancer. Responses are indicated on a 4 point scale for experiences in the past week. A higher score in the sub-scales or total scale indicated greater distress. The positive sub-scale is reverse scored to reflect this.

    Measured: 1 and 4 months post-result disclosure

  5. Knowledge of multigene panel testing score

    A 24 item investigator-developed knowledge scale applicable to this population was developed through an expert panel and in-depth patient cognitive interviews to determine if participants are able to recall key core components about multi-gene panel testing. Each item provides three choice answers: "agree", "disagree", or "I don't know". Knowledge will be scored on the number of "correct" responses where higher correct responses represents more knowledge of multigene panel testing.

    Measured: 4 months post-result disclosure

  6. Family communication for those who tested positive for a genetic mutation

    For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature.

    Measured: 1 and 4 months post-result disclosure

  7. Intent to disclose genetic test results

    Three items will assess participants' intentions to disclose genetic testing results.

    Measured: pre-result disclosure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start21 Nov 2017
  3. Primary completion13 Feb 2020
  4. Study completion13 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
662 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03328091
Sponsor's protocol ID
17-409
Acronym
ProGen
Status last verified
Jan 2024
First submitted
25 Oct 2017
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37733980

  • 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.

    PubMed 36103646

Questions about this trial

What is this clinical trial studying?

A study testing Traditional pre-test genetic counseling and Pre-test video education in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of germline mutations in males with prostate cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03328091, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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