ACTIVE_NOT_RECRUITING

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

Conditions

Prostate Cancer SBRT stereotactic body radiation therapy 21-308 Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-08-04

Study Completion:2026-08-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04997018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Principal Investigator

Victoria Brennan, MBBCH BAO

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering at Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering at Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering at Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Victoria Brennan, MBBCH BAO, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-04

Study Completion Date2026-08-04

Study Record Updates

Study Start Date2021-08-04

Study Completion Date2026-08-04

Terms related to this study

Keywords Provided by Researchers

SBRT
stereotactic body radiation therapy
prostate cancer
21-308
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Prostate Cancer