Description:
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.
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.
Active, not recruiting
Phase 1
Name | Type | Description | Interventions |
---|---|---|---|
MR Image Guided, Intensity-Modulated Radiotherapy | Experimental | 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. |
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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Measure: | Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity |
Time Frame: | 36 months |
Safety Issue: | |
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 |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
August 16, 2021