Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI)

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Apr 14, 2020

Keywords

ClinConnect Summary

The ProsRSI clinical trial is studying a new type of MRI called Restriction Spectrum Imaging (RSI-MRI) to see if it can help predict how well treatment will work for men with high-risk prostate cancer. This trial is aimed at adult males who are planning to receive radiation therapy along with hormone therapy. To be eligible, participants must be at least 18 years old, have confirmed prostate cancer that is considered high-risk, and be in generally good health. They should also be willing to follow all study procedures and attend appointments throughout the trial.

If you participate in this trial, you'll undergo a special MRI scan before starting your treatment. This scan aims to gather information that could help doctors understand how well your prostate cancer responds to treatment. It's important to know that certain medical conditions or prior treatments may exclude someone from participating in the study. Overall, this trial represents an opportunity to contribute to research that could improve future prostate cancer care.

Gender

MALE

Eligibility 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.