A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 120
- Locations
- 7
- Primary Endpoint
- Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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 higher doses of radiation are used each day, the total number of treatment days needed to complete this type of radiation is only five instead of the 45-48 treatments currently used. Treatment takes place every other day and is complete after 2 weeks. If the patient decides to get this treatment, they will come in for 5 treatments. This is different from the 48 treatments they would get normally.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.
Time Frame: With at least one status check visit during the course of treatment.
Secondary Outcomes
- Evaluate the effect of treatment on sexual function.(1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks))
- Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival.(1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks))
- Evaluate pathologic response rates at 24-36 months via repeat biopsy.(24-36 months post treatment)