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.
Brief Title
Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Prostate Cancer
Adenocarcinoma
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
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 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
* 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)
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 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
* 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)
Inclusion 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
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
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
Gender
Male
Gender Based
false
Keywords
prostate
radiation
09-035
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT00911118
Org Class
Other
Org Full Name
Memorial Sloan Kettering Cancer Center
Org Study Id
09-035
Overall Status
Active, not recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase I Dose Escalation Study Using Ultra-Hypofractionated, Image-Guided, Intensity-Modulated Radiotherapy in Prostate Cancer
Primary Outcomes
Outcome Measure
Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer.
Outcome Time Frame
With at least one status check visit during the course of treatment.
Secondary Outcomes
Outcome Time Frame
1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
Outcome Measure
Evaluate post-treatment PSA kinetics and incidence of PSA relapse free survival.
Outcome Time Frame
24-36 months post treatment
Outcome Measure
Evaluate pathologic response rates at 24-36 months via repeat biopsy.
Outcome Time Frame
1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks)
Outcome Measure
Evaluate the effect of treatment on sexual function.
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Madhur Garg
Investigator Email
mgarg@montefiore.org
Investigator Phone