Clinical trial NCT03290508: Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer
Official title: Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Prolaris
Prostate Cancer
Cell Cycle Progression Test
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 524
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed (≤ 6 months), treatment-naïve patients with favorable intermediate-risk localized prostate cancer whose initial treatment has not been decided and who are being seen at Medicare Certification and Training Registry (CTR) practices in the United States.

Brief summary: This is a long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients with Prolaris low-risk scores without negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from unnecessary treatments and associated side-effects.

Detailed description: This is a long-term prospective registry to evaluate the impact of Prolaris testing on therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized prostate cancer and to summarize clinical oncologic outcomes. The design of the study is non-interventional, and therefore the protocol will not require a specific treatment plan for study participants. However, in the absence of a universally accepted timeframe for repeat biopsies within existing active surveillance recommendations, study sites will be encouraged to monitor patients for disease progression as per the standard of care (e.g., current National Comprehensive Cancer Network \[NCCN\] guidelines) with the expectation of a repeat biopsy within 18 months of the initial biopsy.

Patients who undergo Prolaris testing will be included in the registry as well as patients who do not undergo Prolaris testing. Data collection for the first primary objective extends over a 3-year period. During this time, data is collected on the treatment initiated, any follow-up prostate biopsy performed in patients initially treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.

Data collection for the second primary objective extends out to 8 years. During this time data is collected on any follow-up prostate biopsy in patients still treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.

  1. Willing to provide written informed consent.
  2. Males ≥65 years old.
  3. Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided.
  4. Candidate for and considering AS and yet would be eligible for definitive therapy.
  5. Favorable intermediate-risk disease, defined by the NCCN as follows:

     * predominant Gleason grade 3; AND
     * percentage of positive cores \<50%; AND
     * no more than 1 of the following NCCN intermediate-risk factors:

       * Gleason grade 7
       * T2b-T2c
       * PSA 10-20 ng/mL
  6. Estimated life expectancy ≥10 years.
  7. Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).

Exclusion Criteria:

* 1. Clinical evidence of metastasis or lymph node involvement.
* 2. Received pelvic radiation prior to biopsy.
* 3. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted.
* 4. Participation in interventional clinical trials.
* 5. Patient is considering watchful waiting.
* 6. Has a known history of hypogonadism.

Primary outcomes:
measure: Low Prolaris Score, on Active Surveillance
timeFrame: 3 years
measure: Low Prolaris Score, Definitive Treatment Following Active Surveillance
timeFrame: 3 years
measure: Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment
timeFrame: 8 years
Secondary outcomes:
measure: Low Prolaris Score, Time to Definitive Treatment following Active Surveillance
timeFrame: 8 years
measure: No Prolaris Score, on Active Surveillance
timeFrame: 3 years
measure: No Prolaris Score, Definitive Treatment Following Active Surveillance
timeFrame: 3 years
measure: No Prolaris Score, Time to Definitive Treatment Following Active Surveillance
timeFrame: 8 years
measure: No Prolaris Score, Disease Progression Following Delayed Definitive Treatment
timeFrame: 8 years
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Mesa
country: United States
facility: East Valley Urology Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Concord
country: United States
facility: Pacific Urology
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: San Jose
country: United States
facility: Ssg Md Apc
state: California
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Delray Beach
country: United States
facility: Urology Group of Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology
state: Florida
city: Sunrise
country: United States
facility: 21st Century Oncology
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Westchester
country: United States
facility: URO Partners
state: Illinois
city: Wichita
country: United States
facility: Wichita Urology
state: Kansas
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Department of Urologic Oncology
state: Michigan
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Tupelo
country: United States
facility: UroLogic
state: Mississippi
city: Cranford
country: United States
facility: Premier Urology Group, LLC
state: New Jersey
city: Cranford
country: United States
facility: Premier Urology
state: New Jersey
city: Englewood
country: United States
facility: Urologic Research and Consulting LLC
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Syracuse
country: United States
facility: A.M.P. Radiation Oncology
state: New York
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: West Columbia
country: United States
facility: Carolina Urology Partners
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: El Paso
country: United States
facility: Rio Grande Urology
state: Texas
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
Study officials:
References: