Phase I Study MR-guided SBRT to PCa

Not Applicable

Withdrawn

• Conditions: Low or Intermediate Risk Prostate Cancer
• Interventions: Radiation: MR guided Linear Accelerator

• 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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
MR-guided SBRT With SIB to the DILs to Prostate Cancer	MR guided Linear Accelerator	Dose escalation to the DIL(s) will be performed in the traditional Phase I 3+3 design. Patients will be treated in four cohorts (three patients per dose level) starting with a dose of 9 Gy to the DIL(s). If no dose limiting toxicity (DLT), defined below, is observed after 90 days, then an additional three patients will be entered at the next dose level. Dose to the DIL(s) will be escalated at 1 Gy increments until DLT is observed or if maximum dose level (60 Gy in 5 fractions of 12 Gy) is reached with no observed DLT. If one of the three patients experience a DLT at a particular dose level an additional three patients will be enrolled at that level. If two or more patients experience a DLT a lower dose level will be explored to define the maximum tolerated dose (MTD). The three patients within any cohort can be enrolled simultaneously or sequentially without any waiting period among them.

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