A Study of MRI-guided High-dose Radiation Therapy in Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT04997018
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 91
Inclusion Criteria:<br><br> - Intermediate-risk prostate cancer patients will be eligible for this study. Risk<br> groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be<br> defined as:<br><br> - PSA 10-20 ng/ml or<br><br> - Gleason score = 7 or<br><br> - Clinical stage T2b/T2c or<br><br> - Additionally, patients will be required to meet all of the following criteria:<br><br> - Age = 18<br><br> - Karnofsky Performance Status (KPS) = 80 (Appendix 1)<br><br> - Prostate size = 80 cc<br><br> - Presence of a T2-visible prostatic lesion with maximum dimension of = 0.5 cm<br> and no more than one additional disease focus<br><br> - MRI findings: Lesion may contact the capsular edge, possible extracapsular<br> extension (ECE) permitted<br><br> - International Prostate Symptom Score = 15<br><br> - Satisfy all MRI screening criteria and be willing to fill out the standard MRI<br> screening form<br><br>Exclusion Criteria:<br><br>Patient will be excluded if they meet any one of the following criteria:<br><br> - Gleason score >7<br><br> - PSA >20<br><br> - Prior or concurrent androgen deprivation therapy for prostate cancer MRI findings:<br> suspicious for/probable ECE<br><br> - MRI findings: >2 disease foci identifiable<br><br> - Evidence of metastatic disease on bone scan or MRI/CT<br><br> - MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or<br> other implanted metallic or electronic device which is considered MR unsafe; severe<br> claustrophobia; inability to lie flat for the duration of the study; etc.<br><br> - Metallic implant or device in the pelvis that might distort the local magnetic field<br> and compromise quality of mp-MRI<br><br> - Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation<br> greater than 35 cm which are incompatible with MRCAT reconstruction<br><br> - Contra-indications to receiving gadolinium contrast<br><br> - KPS < 80<br><br> - Pelvic or prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1<br> disease<br><br> - Prior history of transurethral resection of the prostate<br><br> - Prior history of urethral stricture<br><br> - Prior history of pelvic irradiation<br><br> - History of inflammatory bowel disease<br><br> - Unable to give informed consent<br><br> - Unable to complete quality of life questionnaires<br><br> - Abnormal complete blood count, including any of the following:<br><br> - Platelet count less than 75,000/ml<br><br> - Hb level less than 10 gm/dl<br><br> - WBC less than 3.5/ml<br><br> - Abnormal renal function tests (creatinine > 1.5)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of pretreatment biopsy with post-treatment biopsy
- Secondary Outcome Measures
Name Time Method