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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349501
• Other study ID #: 200266
• Status: Recruiting
• Phase: Phase 2
• Start date: December 29, 2020
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: University of California, San Diego
• Contact: Gerald Henderson, BA
• Phone: 858-534-4811
• Email: gehenderson[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	UCSD Moores Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 3 years of RT completion
Secondary	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.	within 18 months of RT completion