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

NCT03424850 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 201801118
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 Cancer; Prostate Neoplasm

Outcome Measures

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

  Through 3 years after implant

Secondary Outcomes (2)

• Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant

  From start of treatment through 90 days

• Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant

  From day 91 through 3 years after implant

Other Outcomes (1)

• Optimal dose of radiation

  Through 3 months after completion of implant for all patients enrolled (estimated to be 5 years and 3 months)

Study Arms (3)

HDR brachytherapy - 21 Gy

EXPERIMENTAL

-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

HDR brachytherapy - 23 Gy

EXPERIMENTAL

-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

HDR brachytherapy - 25 Gy

EXPERIMENTAL

-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

Interventions

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%

HDR brachytherapy - 21 Gy; HDR brachytherapy - 23 Gy; HDR brachytherapy - 25 Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hiram A Gay, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiram A Gay, M.D.

CONTACT

314-362-8516; hiramgay@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 7, 2018
• Study Start: February 27, 2018
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)