Prostate Cancer Clinical Trial
A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer
Summary
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.
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 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
Exclusion Criteria:
Patient will be excluded if they meet any one of the following criteria:
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)
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There are 7 Locations for this study
New York New York, 10065, United States More Info
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