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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Neoplasm
• Intervention / Treatment: Radiation: HDR brachytherapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hiram A Gay, M.D.; Phone Number: 314-362-8516; Email: hiramgay@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Joshua Schiff, M.D.
      • Contact: Hiram A Gay, M.D.; Phone Number: 314-362-8516; Email: hiramgay@wustl.edu
      • Principal Investigator: Hiram A Gay, M.D.
      • Sub-Investigator: Jeff M Michalski, M.D.
      • Sub-Investigator: Yi Huang
      • Sub-Investigator: Michael Altman, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 ccUrethra: V115 < 1 ccV135: 0%; Dose constraints for 23 Gy:Bladder and rectum: V65 < 1 ccUrethra: V105 < 1 ccV125: 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 ccUrethra: V115 < 1 ccV135: 0%; Dose constraints for 23 Gy:Bladder and rectum: V65 < 1 ccUrethra: V105 < 1 ccV125: 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 ccUrethra: V115 < 1 ccV135: 0%; Dose constraints for 23 Gy:Bladder and rectum: V65 < 1 ccUrethra: V105 < 1 ccV125: 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Hiram A Gay, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 201801118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No