Targeted radiation therapy for high-risk prostate cancer using advanced imaging
Single-Arm Phase II Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer
This study is testing a new type of targeted radiation therapy using advanced imaging to see if it can help men with high-risk prostate cancer have better treatment outcomes and lower chances of the cancer coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | Male |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04402151 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of PSMA PET/MR guided stereotactic body radiation therapy (SBRT) with simultaneous integrated boost for patients with high-intermediate and high-risk prostate cancer. The study aims to enroll 50 male participants who will receive personalized radiation treatment based on advanced imaging techniques that enhance tumor visualization and treatment precision. By utilizing real-time adaptive planning during radiation delivery, the trial seeks to improve clinical outcomes and reduce recurrence rates in aggressive prostate cancer cases. The approach combines novel imaging with innovative radiation technology to better target areas at risk of cancer recurrence.
Who should consider this trial
Good fit: Ideal candidates are males aged 21 and older with pathologically confirmed high-risk adenocarcinoma of the prostate.
Not a fit: Patients with evidence of metastatic disease or contraindications to the proposed treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce recurrence in patients with high-risk prostate cancer.
How similar studies have performed: While the use of PSMA PET/MR imaging is novel, similar approaches in radiation therapy have shown promise in improving treatment outcomes for localized cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male aged 21 years or older. * Ability to provide signed informed consent and willingness to comply with protocol requirements. * Pathologic confirmation of high-risk adenocarcinoma of the prostate gland as follows: a. Gleason 8-10 or tertiary component 5 disease and/or b. PSA of 20 ng/ml or greater and/or c. Tumor stage of T2c or greater; OR Unfavorable intermediate risk (Gleason 4+3=7, \>50% of cores involved, or 2 or more intermediate risk factors which include Gleason 7 disease, PSA 10-20, or T2b disease) * Participants must agree to use an acceptable form of birth control and utilize condoms for a period of seven days after each PSMA injection, if engaged in sexual activity. * No evidence of metastatic disease, including pelvic lymph nodes. Exclusion Criteria: * Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MR. * Contraindications to PSMA IV administration * Contraindications to prostate SBRT (history of transurethral resection of prostate; prostate size greater than 150 cc; AUA score greater than 20; history of prior radiation to the prostate) * Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment * Patients on or intending to take abiraterone will be excluded
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Silvia Formenti, M.D. — Weill Medical College of Cornell University
- Study coordinator: Fabiana Gregucci, M.D.
- Email: fgr4002@med.cornell.edu
- Phone: 646-962-3110
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.