Status:
ACTIVE_NOT_RECRUITING
Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI)
Lead Sponsor:
University of California, San Diego
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Participants will undergo RSI at three time points: before therapy (MRI #1), after neoadjuvant ADT (MRI #2), and after radiotherapy (MRI #3). Treatment response will be assessed primarily by absence o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04349501
Start Date
December 29 2020
End Date
December 1 2026
Last Update
November 5 2025
Active Locations (1)
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1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093