Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI) (ProsRSI)
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|ClinicalTrials.gov Identifier: NCT04349501|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Restriction Spectrum Imaging Magnetic Resonance Imaging||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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|
|Estimated Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2026|
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.
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.
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, BAemail@example.com|
|Contact: Michelle Padillafirstname.lastname@example.org|
|United States, California|
|UCSD Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Tyler Seibert, MD, PhD||University of California, San Diego|