Prostate Cancer, Prostate Neoplasm
Conditions
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.
Interventions
RADIATIONHDR 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%
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant | From start of treatment through 90 days | -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 | From day 91 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. |
Countries
United States
Contacts
CONTACTHiram A Gay, M.D.
PRINCIPAL_INVESTIGATORHiram A Gay, M.D.
Washington University School of Medicine
Outcome results
None listed