NCT04349501Active, not recruiting
Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI)
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 14 Apr 2020
- Start date
- 29 Dec 2020
- Primary completion date
- Dec 2026
- Lead sponsor
- University of California, San Diego
- Diseases
- Prostate cancer
- NCT number
- NCT04349501
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 29 Dec 2020 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the pelvis
- Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy)
Other illness
- 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)
Lab values
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCSD Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.