Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424850
• Other study ID #: 201801118
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 27, 2018
• Est. completion date: February 28, 2029

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Hiram A Gay, M.D.
• Phone: 314-362-8516
• Email: hiramgay[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2029
• Est. primary completion date: February 28, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

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%

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)
Primary	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	Through 3 years after implant
Secondary	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.	From start of treatment through 90 days
Secondary	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.	From day 91 through 3 years after implant

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine