Clinical trial · Interventional
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
NCT04349501CI-TRIAL-00097012ProsRSIactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Restriction Spectrum Imaging Magnetic Resonance Imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RSI-MRI
- description
- Participants will undergo RSI-MRI at three time points: before androgen deprivation therapy (ADT); after neoadjuvant ADT but before radiation therapy (RT); and after RT.
- interventionNames
- Other: Restriction Spectrum Imaging Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Biochemical recurrence (PSA 2 ng/mL greater than nadir) within 3 years of completing RT.
- timeFrame
- within 3 years of RT completion
- description
- To evaluate the performance of the RSI cellularity index before and during therapy as a biomarker to identify participants who will experience biochemical recurrence within 3 years post-radiotherapy.
Secondary outcomes (1)
- measure
- PSA nadir within the 18 months after RT ≥0.5 ng/mL.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.