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

NCT ID: NCT03424850

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2029-02-28

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.

Conditions

Prostate Neoplasm; Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HDR brachytherapy

Intervention Type: 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%

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.

Group Type: EXPERIMENTAL

HDR brachytherapy

Intervention Type: 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%

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.

Group Type: EXPERIMENTAL

HDR brachytherapy

Intervention Type: 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%

Interventions

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%

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiram A Gay, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hiram A Gay, M.D.

Role: CONTACT

hiramgay@wustl.edu

314-362-8516

Facility Contacts

Hiram A Gay, M.D.

Role: primary

hiramgay@wustl.edu

314-362-8516

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201801118

Identifier Type: -

Identifier Source: org_study_id