Back to resultsRadiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
Primary Purpose
Prostate Cancer
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MR-based image-guided, intensity-modulated radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring 17-407, Intermediate Risk Prostate Cancer, DIL, Dominant Intra-Prostatic Lesion
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
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
Exclusion Criteria:
- 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
Abnormal complete blood count. 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
- Memorial Sloan Kettering Basking Ridge (Consent only and follow up)
- Memorial Sloan Kettering Monmouth
- Memorial Sloan Kettering Bergen
- Memorial Sloan Kettering Commack
- Memorial Sloan Kettering Westchester
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Nassau (Consent and follow up)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MR Image Guided, Intensity-Modulated Radiotherapy
Arm Description
Patients 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03269422
First Posted
August 29, 2017
Last Updated
September 12, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03269422
Brief Title
Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
August 28, 2024 (Anticipated)
Study Completion Date
August 28, 2024 (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
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
17-407, Intermediate Risk Prostate Cancer, DIL, Dominant Intra-Prostatic Lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MR Image Guided, Intensity-Modulated Radiotherapy
Arm Type
Experimental
Arm Description
Patients 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.
Intervention Type
Radiation
Intervention Name(s)
MR-based image-guided, intensity-modulated radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity
Description
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
Time Frame
36 months
10. Eligibility
Sex
Male
Gender Based
Yes
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
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
Exclusion Criteria:
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
Abnormal complete blood count. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Gorovets, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent only and follow up)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent and follow up)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
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Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
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