High-dose radiation therapy for prostate cancer
A Phase II Study of Radiotherapy to the Prostate and Dose Intensification to the Dominant Intra- Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy
This study tests if a new high-dose radiation treatment for prostate cancer can help patients with intermediate-risk cancer get better and have fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 91 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT04997018 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of MRI-guided high-dose radiation therapy, specifically stereotactic body radiation therapy (SBRT), in treating intermediate-risk prostate cancer. The approach involves delivering a higher dose of radiation directly to the main tumor while administering a standard dose to the rest of the prostate. The goal is to determine if this method can improve cancer cure rates and reduce recurrence while minimizing side effects. Eligible patients will be carefully selected based on specific clinical criteria.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with intermediate-risk prostate cancer as defined by specific clinical parameters.
Not a fit: Patients with high-risk prostate cancer or those who have received prior androgen deprivation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the chances of curing intermediate-risk prostate cancer and prolonging remission.
How similar studies have performed: Previous studies using high-dose radiation therapy for prostate cancer have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as: * PSA 10-20 ng/ml or * Gleason score = 7 or * Clinical stage T2b/T2c or * Additionally, patients will be required to meet all of the following criteria: * Age ≥ 18 * Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1) * Prostate size ≤ 80 cc * Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus * MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted * International Prostate Symptom Score ≤ 15 * Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form Exclusion Criteria: Patient will be excluded if they meet any one of the following criteria: * Gleason score \>7 * PSA \>20 * Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE * MRI findings: \>2 disease foci identifiable * Evidence of metastatic disease on bone scan or MRI/CT * MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc. * Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI * Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction * Contra-indications to receiving gadolinium contrast * KPS \< 80 * Pelvic or prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease * Prior history of transurethral resection of the prostate * Prior history of urethral stricture * Prior history of pelvic irradiation * History of inflammatory bowel disease * Unable to give informed consent * Unable to complete quality of life questionnaires * Abnormal complete blood count, including any of the following: * Platelet count less than 75,000/ml * Hb level less than 10 gm/dl * WBC less than 3.5/ml * Abnormal renal function tests (creatinine \> 1.5)
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Victoria Brennan — Basking Ridge, New Jersey, United States (Recruiting)
- Victoria Brennan — Middletown, New Jersey, United States (Recruiting)
- Victoria Brennan — Montvale, New Jersey, United States (Recruiting)
- Victoria Brennan — Commack, New York, United States (Recruiting)
- Victoria Brennan — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Victoria Brennan — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Victoria Brennan, MBBCH BAO — Memorial Sloan Kettering Cancer Center
- Study coordinator: Victoria Brennan, MBBCH BAO
- Email: brennanv@mskcc.org
- Phone: 212-639-8904
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.