Prospective Prolaris Value and Efficacy

Prostate Cancer Clinical Trial

— P-PROVE  

Official title:

Two-Part Prospective Study to Measure Impact of Prolaris® Testing Added to Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients to Measure Prediction of Progression/Recurrence in Men Treated at VAMC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03152448
• Other study ID #: URO-005
• Status: Terminated
• Start date: September 1, 2015
• Est. completion date: March 21, 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 prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer.

Description:

This is a prospective study to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Multiple individual VAMC sites will participate in PART 1 of the study. During PART 1 of the study, a three-part questionnaire will be completed to evaluate the PRE-Prolaris test treatment plan, the POST-Prolaris test treatment plan, and the ACTUAL treatment option. Using PRE-Prolaris Test Questionnaire #1 the physician will record the recommendation for first-line therapy based on standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores). The likelihood of recommending a non-interventional therapy approach will also be recorded using a 10-point ordinal scale. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing and after patient consultation, the physician will complete POST-Prolaris Questionnaire #2 documenting the planned treatment ( interventional treatment or non-interventional). Approximately 6 months from the date of the test results, ACTUAL Treatment Questionnaire #3 will be completed to document the actual treatment administered. PART 2 of this study is a prospective evaluation of the prognostic utility of Prolaris® testing of prostate biopsy samples obtained from men who participate in PART 1of the study and who undergo radical prostatectomy or radiation therapy or who are managed with WW or AS. The central VAMC site will be responsible for PART 2; individual VAMC sites will not participate in this part of the study. Patients will be followed using medical record review every 6 months for objective progression (BCR, radiographic or radionuclide evidence of metastases or disease specific mortality) through 5 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1511
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed (<= 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
• Final treatment decision has not been made (that is all treatment options are feasible and none have been ruled out due to comorbidities at study entry)
• Clinically localized (no evidence on clinical or imaging studies of advanced disease)
• No hormonal therapy for treatment of prostate cancer including LHRH agonist or antagonist, anti-androgen, estrogens or exogenous androgens when applicable (use of 5-alpha reductase inhibitors is acceptable)
• Sufficient amount of tissue remains from biopsy to perform genomic testing
• Life expectance of a minimum of 10 years
• Men who completed PART 1 and were treated with radical prostatectomy (including robotic, laparoscopic, open retropubic or perineal) or receive radiation therapy or were placed on AS or WW.

Exclusion Criteria:

• Men with clinical node positive or metastatic disease
• Men with a known baseline total serum testosterone level of <100 ng/dL prior to radiation or hormone therapy (men with unknown baseline testosterone levels will not be excluded)
• Men who previously received pelvic radiotherapy for another malignancy
• Non adenocarcinoma prostate cancer histologies

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Prolaris
Series of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result

Locations

Country	Name	City	State
United States	James J. Peters VA	Bronx	New York
United States	Ralph H. Johnson VAMC	Charleston	South Carolina
United States	Michael E. DeBakey VAMC	Houston	Texas
United States	Kansas City VAMC	Kansas City	Kansas
United States	Minneapolis VA Healthcare System	Minneapolis	Minnesota
United States	Southeast Louisiana Veterans Healtchare System	New Orleans	Louisiana
United States	Oklahoma City Veteran's Hospital	Oklahoma City	Oklahoma
United States	VA St. Louis Healthcare System	Saint Louis	Missouri
United States	Salt Lake City VA Medical Center	Salt Lake City	Utah
United States	VA San Diego Healthcare System	San Diego	California
United States	James A. Haley Veterans' Hospital	Tampa	Florida
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.	VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prolaris prediction of who benefits from the addition of hormone therapy to contemporary radiation therapy	either biochemical or objective recurrences of disease following definitive therapy with curative intent in men treated with radiation who did or did not receive adjuvant ADT	5 years
Other	Comparison of prognostic utility of prospective Prolaris testing of prostate biopsy samples to other clinical pathological parameters with respect to disease progression	either biochemical or objective recurrences of disease following definitive therapy with curative intent in men treated with radical prostatectomy or radiation	5 years
Other	Association of Prolaris score with progression to active intervention when initially managed with AS or WW	Progression to interventional therapy in men initially managed with AS or WW	5 years
Other	Prognostic utility of Prolaris testing compared to other clinical pathological parameters with respect to disease progression in men who were Gleason score <7 on initial biopsy	biochemical or objective recurrence of disease in men who were Gleason score <7	5 years
Other	Impact of Prolaris on magnitude of change between pre-Prolaris treatment selection and the post-Prolaris treatment plan following consultation with the patient	comparison of percentage change from the pre-Prolaris treatment option versus the post-Prolaris treatment plan	3 months
Other	Impact of Prolaris on magnitude of change between physician likelihood of recommending non-interventional therapy and the likelihood following the genomic test results	mean change in the physician's likelihood of recommending watchful waiting or active surveillance post-genomic testing compared to pre-genomic testing	3 months
Primary	Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment	Comparison of percentage change from the Pre-Prolaris test treatment option (based on standard clinical pathological parameters) versus the actual treatment option implemented following results of Prolaris	6 months
Primary	Prolaris prediction of biochemical or objective recurrence	Biochemical recurrence (defined as PSA >0.2 ng/ml or by Phoenix definition) or objective recurrences of disease by 5 years following definitive therapy with curative intent in men treatment with radical prostatectomy or radiation therapy	5 years