Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI) (ProsRSI)
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ClinicalTrials.gov Identifier: NCT04349501 |
Recruitment Status :
Recruiting
First Posted : April 16, 2020
Last Update Posted : May 17, 2022
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Other: Restriction Spectrum Imaging Magnetic Resonance Imaging | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | A logistic regression model of biochemical recurrence within 3 years will be fit, using maximum likelihood, on the change in RSI cellularity index from MRI #1 to MRI #2 and relevant covariates such as demographics. Continuous variables will be splined; only main effects will be considered. The cross-validated AUC for this model will be reported with a 95% bootstrap confidence interval using Efron's bias-corrected and accelerated (bca) method. If the lower bound on the 95% confidence interval of the AUC excludes 0.55, RSI cellularity index will be declared "viable" for identifying participants who will recur within the three-year post treatment. If declared "viable", a Cox model for predicting recurrence time will be fit, and the hazard ratios for RSI will be used to describe the adjusted associations supported by the data between RSI cellularity index and recurrence time. |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Actual Study Start Date : | December 29, 2020 |
Estimated Primary Completion Date : | December 1, 2022 |
Estimated Study Completion Date : | December 1, 2026 |

Arm | Intervention/treatment |
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Experimental: RSI-MRI
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.
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Other: Restriction Spectrum Imaging Magnetic Resonance Imaging
RSI is a multicompartment model of diffusion MRI that uses data acquired at multiple b-values to distinguish varied diffusion speeds (restricted intracellular, hindered extracellular, and approximately free diffusion).
Other Name: RSI-MRI |
- Biochemical recurrence (PSA 2 ng/mL greater than nadir) within 3 years of completing RT. [ Time Frame: within 3 years of RT completion ]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.
- PSA nadir within the 18 months after RT ≥0.5 ng/mL. [ Time Frame: within 18 months of RT completion ]To evaluate the performance of the RSI cellularity index for identifying participants who will fail to reach a PSA nadir <0.5 ng/mL within 18 months of RT.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Male subjects undergoing treatment for Prostate Cancer |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349501
Contact: Gerald Henderson, BA | 858-534-4811 | gehenderson@health.ucsd.edu | |
Contact: Michelle Padilla | 858-822-5223 | mlp002@health.ucsd.edu |
United States, California | |
UCSD Moores Cancer Center | Recruiting |
La Jolla, California, United States, 92093 | |
Contact: Michelle Padilla 858-822-5223 mlp002@health.ucsd.edu | |
Contact: Gerald Henderson, BA 858-534-4911 gehenderson@ucsd.edu | |
Principal Investigator: Tyler Seibert, MD, PhD | |
Sub-Investigator: Andrew Sharabi, MD, PhD | |
Sub-Investigator: Brent Rose, MD | |
Sub-Investigator: James Urbanic, MD | |
Sub-Investigator: Arno Mundt, MD | |
Sub-Investigator: Ajay Sandhu, MD, DMRT | |
Sub-Investigator: John Einck, MD |
Principal Investigator: | Tyler Seibert, MD, PhD | University of California, San Diego |
Responsible Party: | Tyler Seibert, Assistant Professor, Radiation Medicine and Applied Sciences, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT04349501 |
Other Study ID Numbers: |
200266 |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | May 17, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |