Clinical trial NCT04995198: PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
Official title: PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Genetics
Registry
Germline Mutation
Genetic Testing
Germline Testing
Lead sponsor: Prostate Cancer Clinical Trials Consortium
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
name: Fred Hutchinson Cancer Center
name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Advancing Cancer Treatment, Inc.
First posted: 2021-08-06
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with prostate cancer (any stage of disease or survivorship). Individuals are eligible whether they have had prior germline genetic testing or not.

Brief summary: PROMISE aims to create a comprehensive nationwide registry of prostate cancer patients with germline pathogenic variants by prospectively screening approximately 5,000 subjects with a confirmed prostate cancer diagnosis, either through tissue biopsy, PSA greater than 100 ng/dL and/or radiographic evidence of disease and receiving systemic therapy for prostate cancer. Patients at all stages of disease will be welcome to participate in the PROMISE Registry.

Participants will be recruited \& screened over a five-year period. Study participants will be asked to provide a saliva sample to be tested for germline cancer risk variants through Color Health. If the results identify a pathogenic or likely pathogenic variant, an appointment with a genetic counselor from Color Health will be scheduled to discuss the results.

Participants will complete a baseline demographic survey that includes self-reported health history, family history of cancer and standardized patient reported outcome (PRO) measures.

PROMISE Registry staff will request medical records from the participant's cancer care provider(s) for the purpose of obtaining clinical data.

Participants will receive bi-annual newsletters offering information on new developments in treatment and research opportunities, including clinical trials, associated with genetic variants.

Eligible participants (those with target germline mutations) will be followed every 6 months to obtain updated health records data and patient-reported outcomes data. Participants will be followed for a minimum of 15 years.

The PROMISE registry will help identify prostate cancer patients with pathogenic variants to learn more about how these variants affect patient outcomes. Ultimately, we hope to help patients learn more about their disease and the treatments that they may derive the most benefit from, including the germline genetic biomarker-based clinical trials they may be eligible for.

For more information, visit the study website at: prostatecancerpromise.org


Eligibility 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

Primary outcomes:
measure: Frequency of at least one germline pathogenic or likely pathogenic variant
timeFrame: 5 years
Secondary outcomes:
measure: Frequency of pathogenic or likely pathogenic germline variants of interest
timeFrame: 5 years
measure: Identify and recruit control group of patients with a variant of uncertain significance (VUS)
timeFrame: 5 years
measure: Association between disease characteristics and genetic variants
timeFrame: 15 years
measure: Analysis of patient reported outcomes (PRO) measures
timeFrame: 15 years
measure: Analysis of longitudinal outcome data
timeFrame: 15 years
measure: Comparison of overall survival
timeFrame: 15 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Heather Cheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Channing Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: