Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
Tyler Seibert, MD, PhD
Photo of Tyler Seibert
Tyler Seibert

Description

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.

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

Details

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.

Keywords

Prostate Cancer Prostatic Neoplasms Restriction Spectrum Imaging Magnetic Resonance Imaging RSI-MRI

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Location

  • UCSD Moores Cancer Center
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Tyler Seibert, MD, PhD
    Assistant Professor In Residence, Radiation Medicine and Applied Science. Authored (or co-authored) 42 research publications. Research interests: Radiation Oncology · Quantitative Imaging · MRI · Polygenic Hazard Score · Polygenic Risk.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04349501
Phase
Phase 2
Study Type
Interventional
Last Updated