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

Clinicaltrials.gov ID: NCT04349501
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 100

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Tyler Seibert, MD, PhD

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.

Study Plan

RSI-MRI

EXPERIMENTAL

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

    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).

Outcome Measures

Primary Outcome Measures

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

Time Frame: within 3 years of RT completion

Secondary Outcome Measures

PSA nadir within the 18 months after RT u22650.5 ng/mL.

Time Frame: within 18 months of RT completion

Timeline

  • Last Updated
    January 26, 2024
  • Start Date
    April 16, 2020
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    December 1, 2026

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