Stereotactic body radiation therapy for unfavorable intermediate-risk prostate cancer without hormone therapy
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
This study is testing if a special type of radiation therapy can help men with a certain kind of prostate cancer avoid recurrence without using hormone therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 215 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05169970 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of stereotactic body radiation therapy (SBRT) as a treatment for patients with unfavorable intermediate-risk prostate cancer, without the use of androgen deprivation therapy (ADT). Researchers aim to determine if SBRT can prevent cancer recurrence and metastasis, while also evaluating the safety and efficacy of using Decipher genomic test results to identify patients who may benefit from more intensive radiation treatments. The study will involve patients who meet specific clinical criteria and will be conducted at multiple locations affiliated with Memorial Sloan Kettering Cancer Center.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a recent diagnosis of unfavorable intermediate-risk prostate cancer who meet specific clinical and genomic criteria.
Not a fit: Patients with advanced prostate cancer (T3-T4) or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with unfavorable intermediate-risk prostate cancer, potentially improving outcomes without the side effects associated with hormone therapy.
How similar studies have performed: Other studies have shown promising results with SBRT in prostate cancer treatment, suggesting that this approach may be effective, though the specific combination with genomic testing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 * cT2b-T2c * 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 * IPSS ≤ 20 * Age ≥ 18 * KPS ≥ or ECOG 0-2 * Estimated life expectancy \>5 years * Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Gorovets, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Daniel Gorovets, MD
- Email: gorovetd@mskcc.org
- Phone: 212-639-3983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.