Status:
ACTIVE_NOT_RECRUITING
Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Montefiore Medical Center
Conditions:
Prostate Cancer
Adenocarcinoma
Eligibility:
MALE
18-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety of a new type of IG-IMRT called "ultra-hypofractionated IG-IMRT" where a higher dose of radiation is given to the tumor during each treatment day. Since...
Eligibility Criteria
Inclusion
- Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient.
- Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines.
- Low risk patients will be defined as:
- PSA \< or = to 10 ng/ml and
- Gleason score = 6 and
- Clinical Stage \< or = to T2a
- 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 \> or = to 18
- KPS \> or = to 70
- Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease
- Prostate size \< or = to 60 cc
- International Prostate Symptom Score \< or = to 15
Exclusion
- Prior androgen deprivation therapy for prostate cancer
- Elective pelvic lymph node irradiation
- KPS \< 70
- Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease
- Presence of distant metastasis as determined by:
- o alkaline phosphatase \> or = to ULN or
- whole body bone scan positive for osseous metastases
- 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)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00911118
Start Date
May 1 2009
End Date
May 1 2026
Last Update
June 3 2025
Active Locations (7)
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1
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
2
Memorial Sloan Kettering West Harrison
Harrison, New York, United States, 10604
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States