Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03290508
• Other study ID #: URO-008
• Status: Terminated
• Start date: September 14, 2017
• Est. completion date: January 14, 2022

Study information

• Verified date: June 2022
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 524
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Prolaris Testing
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Michigan, Department of Urologic Oncology	Ann Arbor	Michigan
United States	Tufts Medical Center	Boston	Massachusetts
United States	Seattle Urology Research Center	Burien	Washington
United States	Medical University of South Carolina	Charleston	South Carolina
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	Pacific Urology	Concord	California
United States	Premier Urology	Cranford	New Jersey
United States	Premier Urology Group, LLC	Cranford	New Jersey
United States	Advanced Urology Institute	Daytona Beach	Florida
United States	Urology Group of Florida	Delray Beach	Florida
United States	Rio Grande Urology	El Paso	Texas
United States	Urologic Research and Consulting LLC	Englewood	New Jersey
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Arkansas Urology	Little Rock	Arkansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	VA Long Beach Healthcare	Long Beach	California
United States	East Valley Urology Center	Mesa	Arizona
United States	Urology Associates	Nashville	Tennessee
United States	UCI Medical Center	Orange	California
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Comprehensive Urology	Royal Oak	Michigan
United States	Pinellas Urology	Saint Petersburg	Florida
United States	Ssg Md Apc	San Jose	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Regional Urology	Shreveport	Louisiana
United States	Stony Brook University	Stony Brook	New York
United States	21st Century Oncology	Sunrise	Florida
United States	A.M.P. Radiation Oncology	Syracuse	New York
United States	Michigan Institute of Urology	Troy	Michigan
United States	UroLogic	Tupelo	Mississippi
United States	Carolina Urology Partners	West Columbia	South Carolina
United States	URO Partners	Westchester	Illinois
United States	Wichita Urology	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Prolaris Score, on Active Surveillance	Proportion of patients with low Prolaris scores who are initially treated with active surveillance	3 years
Primary	Low Prolaris Score, Definitive Treatment Following Active Surveillance	Proportion of patients with low Prolaris scores and initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up	3 years
Primary	Low Prolaris Score, Disease Progression Following Delayed Definitive Treatment	Proportion of patients with low Prolaris scores and initially treated with active surveillance and later proceed to definitive treatment who develop disease progression at 5 years subsequent to the start of definitive treatment.	8 years
Secondary	Low Prolaris Score, Time to Definitive Treatment following Active Surveillance	Time to definitive treatment in patients with low Prolaris scores who are initially treated with active surveillance.	8 years
Secondary	No Prolaris Score, on Active Surveillance	Proportion of patients without Prolaris testing who are initially treated with active surveillance.	3 years
Secondary	No Prolaris Score, Definitive Treatment Following Active Surveillance	Proportion of patients without Prolaris testing initially treated with active surveillance who proceed to definitive treatment at 3 year follow-up.	3 years
Secondary	No Prolaris Score, Time to Definitive Treatment Following Active Surveillance	Time to definitive treatment in patients without Prolaris testing who are initially treated with Active Surveillance.	8 years
Secondary	No Prolaris Score, Disease Progression Following Delayed Definitive Treatment	Proportion of patients without Prolaris testing and initially treated with active surveillance who proceed with definitive treatment that develop disease progression at 5 years subsequent to the start of definitive treatment.	8 years