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Phase I Study MR-guided SBRT to PCa (MRgRTPCa)

Primary Purpose

Low or Intermediate Risk Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR guided Linear Accelerator
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low or Intermediate Risk Prostate Cancer focused on measuring prostate cancer, MRI, intraprostatic lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Henry Ford Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-guided SBRT With SIB to the DILs to Prostate Cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

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

Full Information

First Posted
April 30, 2019
Last Updated
February 9, 2022
Sponsor
Henry Ford Health System
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03935308
Brief Title
Phase I Study MR-guided SBRT to PCa
Acronym
MRgRTPCa
Official Title
Phase I Study Of MR-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost (SIB) To the Dominant Intraprostatic Lesion(s) (DILs) in Men With Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The principal investigator left the institution.
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low or Intermediate Risk Prostate Cancer
Keywords
prostate cancer, MRI, intraprostatic lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MR-guided SBRT With SIB to the DILs to Prostate Cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
MR guided Linear Accelerator
Intervention Description
The aim is to perform treatment planning to compute the highest feasible simultaneous boosting dose to the intraprostatic lesion while respecting normal tissue dose constraints. Patients will be treated with MR-guided localization and adaptive planning techniques.
Primary Outcome Measure Information:
Title
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
Description
The study aims to evaluate the safety and feasibility to employ a simultaneous integrated boost to MRI detected dominant intraprostatic lesion(s) during SBRT
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of Life measures using the Epic questionnaire
Description
Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data.
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17482880
Citation
Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.
Results Reference
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PubMed Identifier
28296582
Citation
Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.
Results Reference
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PubMed Identifier
17707266
Citation
Pucar D, Hricak H, Shukla-Dave A, Kuroiwa K, Drobnjak M, Eastham J, Scardino PT, Zelefsky MJ. Clinically significant prostate cancer local recurrence after radiation therapy occurs at the site of primary tumor: magnetic resonance imaging and step-section pathology evidence. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):62-9. doi: 10.1016/j.ijrobp.2007.03.065.
Results Reference
background
PubMed Identifier
21944089
Citation
Turkbey B, Mani H, Shah V, Rastinehad AR, Bernardo M, Pohida T, Pang Y, Daar D, Benjamin C, McKinney YL, Trivedi H, Chua C, Bratslavsky G, Shih JH, Linehan WM, Merino MJ, Choyke PL, Pinto PA. Multiparametric 3T prostate magnetic resonance imaging to detect cancer: histopathological correlation using prostatectomy specimens processed in customized magnetic resonance imaging based molds. J Urol. 2011 Nov;186(5):1818-24. doi: 10.1016/j.juro.2011.07.013. Epub 2011 Sep 25.
Results Reference
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Phase I Study MR-guided SBRT to PCa

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