Status:
TERMINATED
Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer
Lead Sponsor:
Myriad Genetic Laboratories, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
65+ years
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 conse...
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 ...
Eligibility Criteria
Inclusion
- Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study.
- Willing to provide written informed consent.
- Males ≥65 years old.
- Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided.
- Candidate for and considering AS and yet would be eligible for definitive therapy.
- 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
- Estimated life expectancy ≥10 years.
- Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).
Exclusion
- 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.
Key Trial Info
Start Date :
September 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 14 2022
Estimated Enrollment :
524 Patients enrolled
Trial Details
Trial ID
NCT03290508
Start Date
September 14 2017
End Date
January 14 2022
Last Update
June 23 2022
Active Locations (34)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
East Valley Urology Center
Mesa, Arizona, United States, 85206
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Arkansas Urology
Little Rock, Arkansas, United States, 72211