Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
HDR brachytherapy
Radiation* 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%
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: HDR brachytherapy - 21 GyExperimental treatment 1 intervention
Group B: HDR brachytherapy - 23 GyExperimental treatment 1 intervention
Group C: HDR brachytherapy - 25 GyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Biochemical control experienced by patients with prostate cancer treated with an HDR 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
Time frame
Through 3 years after implantSecondary outcomes
1
Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR 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.
Time frame
From start of treatment through 90 days2
Rate of late toxicity experienced by patients with prostate cancer treated with an HDR 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.
Time frame
From day 91 through 3 years after implantOther outcomes
1
Optimal dose of radiation
-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.
Time frame
Through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)Sponsors and contacts
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Source ClinicalTrials.gov