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Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI) (ProsRSI)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Restriction Spectrum Imaging Magnetic Resonance Imaging
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Moores Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RSI-MRI

Arm 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.

Outcomes

Primary Outcome Measures

Biochemical recurrence (PSA 2 ng/mL greater than nadir) within 3 years of completing RT.
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 Outcome Measures

PSA nadir within the 18 months after RT ≥0.5 ng/mL.
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.

Full Information

First Posted
April 14, 2020
Last Updated
May 16, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04349501
Brief Title
Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI)
Acronym
ProsRSI
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (MRI) examination called Restriction Spectrum Imaging (RSI-MRI) to evaluate whether RSI-MRI can predict treatment response.
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 of biochemical recurrence (PSA ≥2 ng/mL greater than nadir) within 3 years of completing radiotherapy. Change in RSI cellularity index from MRI #1 to MRI #2 will be evaluated for prediction of participants who will experience biochemical recurrence within 3 years, using area under the receiver operating characteristic curve. We hypothesize that RSI cellularity index will be an early biomarker for treatment effectiveness in prostate cancer treated with ADT and radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RSI-MRI
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Restriction Spectrum Imaging Magnetic Resonance Imaging
Other Intervention Name(s)
RSI-MRI
Intervention Description
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).
Primary Outcome Measure Information:
Title
Biochemical recurrence (PSA 2 ng/mL greater than nadir) within 3 years of completing RT.
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.
Time Frame
within 3 years of RT completion
Secondary Outcome Measure Information:
Title
PSA nadir within the 18 months after RT ≥0.5 ng/mL.
Description
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.
Time Frame
within 18 months of RT completion

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male subjects undergoing treatment for Prostate Cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Henderson, BA
Phone
858-534-4811
Email
gehenderson@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Padilla
Phone
858-822-5223
Email
mlp002@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler Seibert, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Padilla
Phone
858-822-5223
Email
mlp002@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Gerald Henderson, BA
Phone
858-534-4911
Email
gehenderson@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Tyler Seibert, MD, PhD
First Name & Middle Initial & Last Name & Degree
Andrew Sharabi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Brent Rose, MD
First Name & Middle Initial & Last Name & Degree
James Urbanic, MD
First Name & Middle Initial & Last Name & Degree
Arno Mundt, MD
First Name & Middle Initial & Last Name & Degree
Ajay Sandhu, MD, DMRT
First Name & Middle Initial & Last Name & Degree
John Einck, MD

12. IPD Sharing Statement

Learn more about this trial

Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI)

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