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

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

Adult male patients with high-risk, localized prostate cancer and planning to undergo radiation therapy (RT) with androgen deprivation therapy (ADT) will undergo an advanced Magnetic Resonance Imaging (MRI) examination called Restriction Spectrum Imaging (RSI-MRI) to evaluate whether RSI-MRI can predict treatment response.

Key facts

Study ID

NCT04349501

Run by

University of California, San Diego

People needed

100

Starts

2020-12-29

Expected to finish

2026-12-01

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 Eastern Cooperative Oncology Group (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

You may not qualify if…

• 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 it is running

• UCSD Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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