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A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring SBRT, stereotactic body radiation therapy, prostate cancer, 21-308, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

Inclusion Criteria:

  • Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as:

    • PSA 10-20 ng/ml or
    • Gleason score = 7
    • Clinical stage T2b/T2c

  • Additionally, patients will be required to meet all of the following criteria:

    • Age ≥ 18
    • Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1)
    • Prostate size ≤ 80 cc
    • Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus
    • MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
    • International Prostate Symptom Score ≤ 15
    • Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form

Exclusion Criteria:

Patient will be excluded if they meet any one of the following criteria:

  • Gleason score >7
  • PSA >20
  • Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE
  • MRI findings: >2 disease foci identifiable
  • Evidence of metastatic disease on bone scan or MRI/CT
  • MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc.
  • Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
  • Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
  • Contra-indications to receiving gadolinium contrast
  • KPS < 80
  • Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
  • Prior history of transurethral resection of the prostate
  • Prior history of urethral stricture
  • Prior history of pelvic irradiation
  • History of inflammatory bowel disease
  • Unable to give informed consent
  • Unable to complete quality of life questionnaires

  • Abnormal complete blood count, including any of the following:

    • Platelet count less than 75,000/ml
    • Hb level less than 10 gm/dl
    • WBC less than 3.5/ml
  • Abnormal renal function tests (creatinine > 1.5)

Sites / Locations

  • Victoria BrennanRecruiting
  • Victoria BrennanRecruiting
  • Victoria BrennanRecruiting
  • Victoria BrennanRecruiting
  • Victoria BrennanRecruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Victoria BrennanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate cancer patients

Arm Description

Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as: PSA 10-20 ng/ml or Gleason score = 7 Clinical stage T2b/T2c

Outcomes

Primary Outcome Measures

Comparison of pretreatment biopsy with post-treatment biopsy
The primary outcome of efficacy will be studied using post -treatment biopsies. To demonstrate efficacy of dose escalation to the DIL, the investigators aim to reduce the positive post-treatment biopsy rates at 24 months for intermediate risk disease from 20% to 10%.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
August 22, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04997018
Brief Title
A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer
Official Title
A Phase II Study of Radiotherapy to the Prostate and Dose Intensification to the Dominant Intra- Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
August 4, 2026 (Anticipated)
Study Completion Date
August 4, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
One of the usual approaches to treating intermediate-risk prostate cancer is a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT delivers higher than standard doses of radiation over a lower number of treatment sessions. However, there is a 20% chance that intermediate-risk prostate cancer will come back after this treatment. The purpose of this study is to find out whether giving an even higher dose (a "boost" dose) of radiation directly to the main tumor and the standard dose of radiation to the rest of the prostate may cure the cancer or prevent it from coming back for a longer period of time while causing few side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
SBRT, stereotactic body radiation therapy, prostate cancer, 21-308, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostate cancer patients
Arm Type
Experimental
Arm Description
Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as: PSA 10-20 ng/ml or Gleason score = 7 Clinical stage T2b/T2c
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
SBRT
Intervention Description
Patients enrolled in this study will undergo ultra-hypofractionated radiation utilizing MR guided, daily online adaptive planning. Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously-delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm, as determined on the pretreatment diagnostic T2 MRI imaging. In the setting of two similarly-sized "dominant" lesions, both will be boosted.
Primary Outcome Measure Information:
Title
Comparison of pretreatment biopsy with post-treatment biopsy
Description
The primary outcome of efficacy will be studied using post -treatment biopsies. To demonstrate efficacy of dose escalation to the DIL, the investigators aim to reduce the positive post-treatment biopsy rates at 24 months for intermediate risk disease from 20% to 10%.
Time Frame
24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as: PSA 10-20 ng/ml or Gleason score = 7 or Clinical stage T2b/T2c or Additionally, patients will be required to meet all of the following criteria: Age ≥ 18 Karnofsky Performance Status (KPS) ≥ 80 (Appendix 1) Prostate size ≤ 80 cc Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than one additional disease focus MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted International Prostate Symptom Score ≤ 15 Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form Exclusion Criteria: Patient will be excluded if they meet any one of the following criteria: Gleason score >7 PSA >20 Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings: suspicious for/probable ECE MRI findings: >2 disease foci identifiable Evidence of metastatic disease on bone scan or MRI/CT MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction Contra-indications to receiving gadolinium contrast KPS < 80 Pelvic or prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease Prior history of transurethral resection of the prostate Prior history of urethral stricture Prior history of pelvic irradiation History of inflammatory bowel disease Unable to give informed consent Unable to complete quality of life questionnaires Abnormal complete blood count, including any of the following: Platelet count less than 75,000/ml Hb level less than 10 gm/dl WBC less than 3.5/ml Abnormal renal function tests (creatinine > 1.5)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Brennan, MBBCH BAO
Phone
212-639-8904
Email
brennanv@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Zelefsky, MD
Phone
212-639-6802
Email
zelefskm@MSKCC.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Brennan, MBBCH BAO
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Brennan
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Brennan, MBBCH BAO
Phone
212-639-8904
Email
brennanv@mskcc.org
Facility Name
Victoria Brennan
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Brennan, MBBCH BAO
Phone
212-639-8904
Email
brennanv@mskcc.org
Facility Name
Victoria Brennan
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Brennan, MBBCH BAO
Phone
212-639-8904
Email
brennanv@mskcc.org
Facility Name
Victoria Brennan
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Brennan, MBBCH BAO
Phone
212-639-8904
Email
brennanv@mskcc.org
Facility Name
Victoria Brennan
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Brennan, MBBCH BAO
Phone
212-639-8904
Email
brennanv@mskcc.org
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Brennan, MBBCH BAO
Phone
212-639-8904
Facility Name
Victoria Brennan
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Brennan, MBBCH BAO
Phone
212-639-8904
Email
brennanv@mskcc.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer

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