Registry for prostate cancer outcomes and genetic mutations
PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
This study is trying to collect information from prostate cancer patients with specific genetic changes to see how these changes affect their health and to offer them genetic counseling.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Prostate Cancer Clinical Trials Consortium Academic / other |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT04995198 on ClinicalTrials.gov |
What this trial studies
The PROMISE Registry aims to establish a nationwide database of prostate cancer patients who have germline pathogenic variants. It will prospectively screen around 5,000 individuals diagnosed with prostate cancer through various methods, including tissue biopsy and PSA levels. Participants will provide saliva samples for genetic testing and complete a demographic survey regarding their health and family history. If a pathogenic variant is identified, they will receive genetic counseling to discuss the implications of the results.
Who should consider this trial
Good fit: Ideal candidates include men diagnosed with prostate cancer at any stage who can provide the necessary information for participation.
Not a fit: Patients who are unable or unwilling to provide the required information or do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of genetic factors in prostate cancer, leading to improved treatment strategies and patient outcomes.
How similar studies have performed: Other studies focusing on genetic factors in cancer have shown promise, indicating that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following: * tissue biopsy, and/or * PSA greater than 100 ng/dL (1ng/ml), and/or * clear radiographic evidence of disease * Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands) Exclusion Criteria: * Unable or unwilling to provide all of the necessary information for eligibility * Incomplete inclusion criteria
Where this trial is running
Baltimore, Maryland and 2 other locations
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of Washington Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Heather Cheng, MD, PhD — Fred Hutchinson Cancer Center
- Study coordinator: Jacob Vinson
- Email: pcctcpromise@mskcc.org
- Phone: 646-449-3363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.