Study on Stereotactic Body Radiation Therapy Without Hormone Therapy for Unfavorable Intermediate-Risk Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT05169970
This clinical trial is exploring whether using stereotactic body radiation therapy (SBRT) alone, without hormone therapy, is effective in treating men with unfavorable intermediate-risk prostate cancer. The study will assess if this approach can prevent the cancer from returning or spreading, and evaluate the safety and effectiveness of using Decipher test results to guide treatment decisions.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if stereotactic body radiation therapy (SBRT) without the use of hormone therapy is an effective treatment for men with unfavorable intermediate-risk prostate cancer. Researchers aim to find out if SBRT can stop the cancer from coming back or spreading to other areas of the body. Additionally, the study will examine the safety and effectiveness of using Decipher test results to decide which patients might need more extensive radiation treatments.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate adenocarcinoma within the last 12 months.
- Classified as having unfavorable intermediate-risk prostate cancer based on specific guidelines, which may include:
- Gleason Score of 4+3.
- 50% or more of biopsy samples showing cancer.
- Two or more of the following risk factors:
- Grade Group 2 or 3.
- Tumor stage cT2b-T2c.
- PSA levels between 10 and 20 ng/mL.
- Able to have an MRI for initial staging and radiation planning.
- Enough biopsy tissue available for Decipher genomic testing.
- Prostate size less than 90cc.
- IPSS score of 20 or less.
- Age 18 or older.
- Good overall health with a performance status score of 0 to 2.
- Expected to live more than 5 years.
- Willing to provide written consent and authorization for the use of health information.
Exclusion Criteria
- Advanced tumor stage (T3-T4) detected on MRI.
- Evidence of cancer spread to distant areas or pelvic lymph nodes on imaging tests.
- Previous treatment for prostate cancer, including chemotherapy, surgery, or hormone therapy.
- Previous radiation treatment to the pelvic area.
- Active second cancer or history of cancer within the last 2 years, except for certain early-stage cancers.
- Recent prostate procedures like TURP or greenlight PVP within 6 months.
- History of Crohn's Disease or Ulcerative Colitis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (All Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (All Protocol Activities) | 11553 | Uniondale | New York |
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