A Phase II Study of Decipher-Guided Dose Escalated Radiation Therapy In Unfavorable Intermediate Risk Prostate Cancer Patients Treated SBRT Alone Without Androgen Deprivation Therapy

Memorial Sloan Kettering Cancer Center7 sites in 1 country215 target enrollmentDecember 9, 2021

ConditionsProstate Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 215
Locations: 7
Primary Endpoint: Rate of biochemical progression free survival
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments

Registry

clinicaltrials.gov

Start Date

December 9, 2021

End Date

December 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment
•Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features:
•Gleason Score 4+3
•≥ 50% biopsy cores positive
•Two or more of the following risk factors:
•Grade Group 2 or 3
•PSA 10 - 20 ng/mL
•Able to undergo MRI for initial staging and MR based radiation planning
•Sufficient biopsy tissue available for Decipher genomic testing
•Prostate volume \< 90cc

Exclusion Criteria

•Radiographic T3-T4 detected on staging mpMRI
•°Must be "consistent with" (\>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist.
•Evidence of distant metastases as determined by MRI, PET, or CT imaging
•Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging
•Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
•Prior pelvic radiation
•Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
•TURP or greenlight PVP within 6 months of enrollment
•History of Crohn's Disease or Ulcerative Colitis