Monitoring prostate cancer treatment response using advanced MRI
A Phase II Biomarker Study of Restriction Spectrum Imaging (RSI) MRI in Patients With High-Risk, Localized Prostate Cancer Who Will Receive Radiotherapy and Androgen Deprivation Therapy
This study is testing if a special type of MRI can help predict how well treatment works for adult men with high-risk prostate cancer who are receiving radiation and hormone therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04349501 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Restriction Spectrum Imaging (RSI-MRI) in predicting treatment response in adult male patients with high-risk, localized prostate cancer undergoing radiation therapy and androgen deprivation therapy. Participants will undergo MRI scans at three different time points: before therapy, after neoadjuvant therapy, and after radiotherapy. The primary outcome is to assess the absence of biochemical recurrence within three years post-treatment, using changes in the RSI cellularity index as a potential early biomarker for treatment effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older with high-risk, localized prostate cancer planning to undergo radiation therapy and androgen deprivation therapy.
Not a fit: Patients who have previously received treatment for prostate cancer or have contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved prediction of treatment outcomes for prostate cancer patients, allowing for more personalized treatment plans.
How similar studies have performed: While the use of advanced MRI techniques in cancer treatment monitoring is gaining traction, this specific application of RSI-MRI in prostate cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate * High-risk prostate cancer (any of: PSA ≥20 ng/mL or cT3-T4 stage or Gleason score ≥8) * Intended treatment and follow-up according to standard of care for prostate cancer * Planning to undergo definitive radiotherapy with neoadjuvant and concurrent androgen deprivation therapy * In good general health as evidenced by medical history and ECOG performance status 0-2 * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Prior radiotherapy to the pelvis * Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy) * Hip prosthesis * Contraindication to MRI, per institutional requirements * Technetium-99 bone scan showing no clear evidence of distant metastasis * MRI or CT scan of the pelvis showing no clear evidence of bone or distant metastasis * Another malignancy, unless in remission or unlikely to impact the patient's survival or ability to receive standard care for prostate cancer (e.g., cutaneous basal cell carcinoma) * Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Where this trial is running
La Jolla, California
- UCSD Moores Cancer Center — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Tyler Seibert, MD, PhD — University of California, San Diego
- Study coordinator: Gerald Henderson, BA
- Email: gehenderson@health.ucsd.edu
- Phone: 858-534-4811
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.