Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy
Study Details
Study Description
Brief Summary
The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HDR brachytherapy - 21 Gy -All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy. |
Radiation: HDR brachytherapy
Dose constraints for 21 Gy:
Bladder and rectum: V70 < 1 cc
Urethra: V115 < 1 cc
V135: 0%
Dose constraints for 23 Gy:
Bladder and rectum: V65 < 1 cc
Urethra: V105 < 1 cc
V125: 0%
Dose constraints for 25 Gy:
Prostate V100 >90% (>95% preferred)
Bladder and rectum: V70 < 1 cc, Dmax <115%
Urethra: V110 < 1 cc, Dmax <120%
|
| Experimental: HDR brachytherapy - 23 Gy -All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy. |
Radiation: HDR brachytherapy
Dose constraints for 21 Gy:
Bladder and rectum: V70 < 1 cc
Urethra: V115 < 1 cc
V135: 0%
Dose constraints for 23 Gy:
Bladder and rectum: V65 < 1 cc
Urethra: V105 < 1 cc
V125: 0%
Dose constraints for 25 Gy:
Prostate V100 >90% (>95% preferred)
Bladder and rectum: V70 < 1 cc, Dmax <115%
Urethra: V110 < 1 cc, Dmax <120%
|
| Experimental: HDR brachytherapy - 25 Gy -All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy. |
Radiation: HDR brachytherapy
Dose constraints for 21 Gy:
Bladder and rectum: V70 < 1 cc
Urethra: V115 < 1 cc
V135: 0%
Dose constraints for 23 Gy:
Bladder and rectum: V65 < 1 cc
Urethra: V105 < 1 cc
V125: 0%
Dose constraints for 25 Gy:
Prostate V100 >90% (>95% preferred)
Bladder and rectum: V70 < 1 cc, Dmax <115%
Urethra: V110 < 1 cc, Dmax <120%
|
Outcome Measures
Primary Outcome Measures
- Biochemical control experienced by patients with prostate cancer treated with an HDR implant [Through 3 years after implant]
-Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng/mL or more above the PSA nadir
Secondary Outcome Measures
- Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant [Through 3 years after implant]
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant [Through 3 years after implant]
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- Optimal dose of radiation [Through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)]
-The optimal dose is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity within the DLT assessment period (3 months after implant) OR the maximally administered dose if fewer than 2 patients in that cohort experience DLT.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically or cytologically confirmed diagnosis of early stage prostate cancer.
-
Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA < 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores < 50%, no more than one NCCN intermediate risk factor).
-
Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.
-
At least 18 years of age.
-
ECOG performance status ≤ 2
-
Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
-
Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.
-
A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.
-
Currently receiving any other investigational agents.
-
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
-
Unable to undergo general, spinal or local anesthesia.
-
Prior TURP
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Hiram A Gay, M.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 201801118