Phase I Study MR-guided SBRT to PCa

Not Applicable

Withdrawn

• Conditions: Low or Intermediate Risk Prostate Cancer

• Registration Number: NCT03935308
• Lead Sponsor: Henry Ford Health System

Brief Summary

1) investigate the feasibility, tolerance, and safety of dose escalation via MR-guided stereotactic body radiation therapy and simultaneous integrated boost to the dominant intraprostatic lesions (DILs), 2) to assess the feasibility of DIL visualization based on multi-parametric MRI (mpMRI), and 3) to characterize longitudinal changes in imaging characteristics and identify urinary biomarkers for treatment response prediction

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Primary Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-25
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically confirmed prostate adenocarcinoma.
• Patients with low or favorable intermediate risk prostate cancer and patients with unfavorable intermediate risk prostate cancer who decline androgen deprivation therapy
• Pretreatment evaluations must be completed as specified in Section 4.0
• Patients must sign a study-specific informed consent form prior to study participation.
• No contraindication to MRI. For example, patients with metal fragments or implanted devices such as pacemakers and aneurysm clips may not be eligible for the study
• At least one intraprostatic lesion can be identified on the mpMR images.
• Patients agree to have hydrogel placed.

Exclusion Criteria

• Patients who have a contraindication to contrast-enhanced MRI are not eligible. Patients with an implanted device such as a pacemaker or metal fragments are not eligible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose to DILs until dose limiting toxicity (>=3 grade 3 GI/GU toxicity) is observed or if maximum dose level is reached	2 years	The study aims to evaluate the safety and feasibility to employ a simultaneous integrated boost to MRI detected dominant intraprostatic lesion(s) during SBRT

Secondary Outcome Measures

Name	Time	Method
Quality of Life measures using the Epic questionnaire	2 years	Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States