Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy
1 other identifier
interventional
35
1 country
7
Brief Summary
The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started Aug 2017
Longer than P75 for phase_1 prostate-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2017
CompletedFirst Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 28, 2026
September 30, 2025
September 1, 2025
9 years
August 29, 2017
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
36 months
Study Arms (1)
MR Image Guided, Intensity-Modulated Radiotherapy
EXPERIMENTALPatients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.
Interventions
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 pre-treatment diagnostic T2 MRI imaging.
Eligibility Criteria
You may qualify if:
- 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
- Additionally, patients will be required to meet the following criteria:
- Age \>18
- KPS \> 80
- Prostate size \< 60cc
- Presence of a prostatic lesion with maximum dimension of \>/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion.
- International Prostrate Symptom Score \< 15
- Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria
You may not qualify if:
- Prior androgen deprivation therapy for prostate cancer
- 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 or inability to lie flat for the duration of the study, etc.
- Metallic hip implant, 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 chronic prostatitis
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent only and follow up)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent and follow up)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Gorovets, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2017
First Posted
August 31, 2017
Study Start
August 28, 2017
Primary Completion (Estimated)
August 28, 2026
Study Completion (Estimated)
August 28, 2026
Last Updated
September 30, 2025
Record last verified: 2025-09