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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04997018
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiation Therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 91 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 4, 2021
Estimated Primary Completion Date : August 4, 2023
Estimated Study Completion Date : August 4, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prostate cancer patients

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
 Radiation: Radiation Therapy
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.
Other Name: SBRT


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of pretreatment biopsy with post-treatment biopsy [ Time Frame: 24 months ]
    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%.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
    • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997018


Contacts
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Contact: Victoria Brennan, MBBCH BAO 212-639-8904 brennanv@mskcc.org
Contact: Michael Zelefsky, MD 212-639-6802 zelefskm@MSKCC.ORG

Locations
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United States, New Jersey
Victoria Brennan Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Victoria Brennan, MBBCH BAO    212-639-8904    brennanv@mskcc.org   
Victoria Brennan Recruiting
Middletown, New Jersey, United States, 07748
Contact: Victoria Brennan, MBBCH BAO    212-639-8904    brennanv@mskcc.org   
Victoria Brennan Recruiting
Montvale, New Jersey, United States, 07645
Contact: Victoria Brennan, MBBCH BAO    212-639-8904    brennanv@mskcc.org   
United States, New York
Victoria Brennan Recruiting
Commack, New York, United States, 11725
Contact: Victoria Brennan, MBBCH BAO    212-639-8904    brennanv@mskcc.org   
Victoria Brennan Recruiting
Harrison, New York, United States, 10604
Contact: Victoria Brennan, MBBCH BAO    212-639-8904    brennanv@mskcc.org   
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Victoria Brennan, MBBCH BAO    212-639-8904      
Victoria Brennan Recruiting
Uniondale, New York, United States, 11553
Contact: Victoria Brennan, MBBCH BAO    212-639-8904    brennanv@mskcc.org   
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Victoria Brennan, MBBCH BAO Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04997018    
Other Study ID Numbers: 21-308
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
SBRT
stereotactic body radiation therapy
prostate cancer
21-308
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases