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Completed

NCT Number: NCT03328091

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Traditional pre-test genetic counseling

Other

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 education

Other

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

Primary outcomes

  1. Prevalence of germline mutations in males with prostate cancer

    Time frame: 2 years

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

Secondary outcomes

  1. Genetic testing uptake

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  3. Genetic testing satisfaction score

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

    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.

  4. Multidimensional Impact of Cancer Risk Assessment score and subscales

    Time frame: 1 and 4 months post-result disclosure

    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.

  5. Knowledge of multigene panel testing score

    Time frame: 4 months post-result disclosure

    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.

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

    Time frame: 1 and 4 months post-result disclosure

    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.

  7. Intent to disclose genetic test results

    Time frame: pre-result disclosure

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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Barbara Ann Karmanos Cancer Institute
  • University of Texas Southwestern Medical Center

Registry information

Acronym: ProGen

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2017
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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