A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer (NCT05169970)
π©Ί Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (9 items).
Location: Memorial Sloan Kettering Basking Ridge (All Protocol Activities) β Basking Ridge, New Jersey
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Radiographic T3-T4 detected on staging mpMRI Β°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
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (7 Sites)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) β Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities) β Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities) β Montvale, New Jersey
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) β Commack, New York
- Memorial Sloan Kettering Westchester (All Protocol Activities) β Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) β New York, New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) β Uniondale, New York
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.