Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | August 28, 2017 |
End Date: | August 28, 2020 |
Contact: | Michael Zelefsky, MD |
Email: | zelefskm@mskcc.org |
Phone: | 212-639-6802 |
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
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.
radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate
risk prostrate cancer.
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)
We found this trial at
8
sites
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Michael Zelefsky, MD
Phone: 212-639-6802
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Basking Ridge, New Jersey 07920
Phone: 212-639-6802
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500 Westchester Avenue
Harrison, New York 10604
Harrison, New York 10604
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Montvale, New Jersey 07645
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Rockville Centre, New York 11570
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Uniondale, New York 11553
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