What this study is
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.
What's being tested
- HDR brachytherapy
Intervention · 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%
Study details
- Official title
- A Phase I/II Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy
- Sponsor
- Washington University School of Medicine
- Conditions
- Prostate Cancer · Prostate Neoplasm
- Enrolling
- 36 people
- Starts
- 2018-02-27
- Est. completion
- 2030-02-28
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWashington University School of Medicine
St Louis, Missouri, United States
- Hiram A Gay, M.D. · Contact314-362-8516hiramgay@wustl.edu
- Hiram A Gay, M.D. · Principal investigator
- Jeff M Michalski, M.D. · Sub-investigator
- Joshua Schiff, M.D. · Sub-investigator
- Trevor Zimmerman · Sub-investigator
- Michael Altman, Ph.D. · Sub-investigator
Recruiting
Study team
Sponsor
Washington University School of Medicine
Study ID 201801118
Principal investigator
Hiram A Gay, M.D.
Washington University School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.