Adenocarcinoma, Prostate Cancer
Conditions
Keywords
prostate, radiation, 09-035
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.
Interventions
RADIATIONHypofractionated, image-guided, intensity-modulated external beam radiation
A standard dose escalation design is utilized, with the initial treatment assigned as 6.5 Gy/fraction for five fractions to a total dose of 32.5 Gy. For any given dose tier, an initial cohort of 30 patients will be treated. However to adjust for potentially inevaluable patients who dropout prior to a full toxicity collection to assess potential DLTs enrollment of up to five additional patients per cohort can occur, per PI's discretion. Dose escalation will proceed if \< 10% of the 30 patients treated per tier exhibit any dose limiting toxicity (DLT) once the entire tier cohort has a minimum follow-up of 3 months and half the tier cohort has a minimum follow-up of 6 months. Dose escalation to the next tier will occur by increasing the dose per fraction by 0.5 Gy while keeping the fraction number constant at 5, leading to a total dose increase of 2.5 Gy per dose tier.
Sponsors
Memorial Sloan Kettering Cancer Center
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the toxicity of hypofractionated radiation therapy as definitive treatment for low and intermediate risk prostate cancer. | With at least one status check visit during the course of treatment. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Evaluate the effect of treatment on sexual function. | 1, 3, & 6 months (+/- 4 weeks) Months 6 - 36 every 6 months (+/- 4 weeks) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSean McBride, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed