NCT05665738

Brief Summary

This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
34mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Sep 2024Feb 2029

First Submitted

Initial submission to the registry

December 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 11, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

4.5 years

First QC Date

December 16, 2022

Last Update Submit

April 28, 2025

Conditions

Prostate AdenocarcinomaLocalized Prostate Carcinoma

Keywords

BrachytherapyRadiotherapyHigh Dose Rate

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with treatment-related adverse events

    The proportion of participants with reported grade 3 or higher genitourinary (GU) or gastrointestinal (GI) toxicities, as graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.

    Up to 6 months

Secondary Outcomes (3)

  • Mean Prostate Specific Antigen (PSA) Nadir

    Up to 6 months

  • Mean Time to PSA Nadir

    Up to 6 months

  • Mean Change in International Prostate Symptom Score (IPSS) over time

    Up to 6 months

Study Arms (1)

HDR brachytherapy

EXPERIMENTAL

Participants will receive the same radiotherapy technique, methods, and delivery will as standard of care 3 hours apart instead of receiving the radiotherapy on separate days.

Radiation: High Dose Rate Monotherapy

Interventions

High Dose Rate MonotherapyRADIATION

High dose rate brachytherapy delivered in 13.5 Gy x 2 fractions over a single implant procedure 3 hours apart

Also known as: HDR Monotherapy, High dose rate brachytherapy
HDR brachytherapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
  • National Comprehensive Cancer Network low to intermediate risk stratification.
  • No prior treatment for prostate cancer and no prior androgen deprivation therapy.
  • Age \>=18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%.
  • Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

You may not qualify if:

  • Any prior treatment for prostate cancer.
  • Any prior androgen deprivation therapy.
  • Is currently receiving any other investigational agents.
  • Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
  • Contraindications to general anesthesia.
  • Contraindications to radiotherapy.
  • Prior cryosurgery or cryotherapy to the prostate.
  • Prior transurethral resection of the prostate within the previous 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (6)

  • Martell K, Mendez LC, Chung HT, Tseng CL, Alayed Y, Cheung P, Liu S, Vesprini D, Chu W, Wronski M, Szumacher E, Ravi A, Loblaw A, Morton G. Results of 15 Gy HDR-BT boost plus EBRT in intermediate-risk prostate cancer: Analysis of over 500 patients. Radiother Oncol. 2019 Dec;141:149-155. doi: 10.1016/j.radonc.2019.08.017. Epub 2019 Sep 12.

    PMID: 31522882BACKGROUND

  • Viani GA, Arruda CV, Assis Pellizzon AC, De Fendi LI. HDR brachytherapy as monotherapy for prostate cancer: A systematic review with meta-analysis. Brachytherapy. 2021 Mar-Apr;20(2):307-314. doi: 10.1016/j.brachy.2020.10.009. Epub 2021 Jan 15.

    PMID: 33461894BACKGROUND

  • Morton G, McGuffin M, Chung HT, Tseng CL, Helou J, Ravi A, Cheung P, Szumacher E, Liu S, Chu W, Zhang L, Mamedov A, Loblaw A. Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Radiother Oncol. 2020 May;146:90-96. doi: 10.1016/j.radonc.2020.02.009. Epub 2020 Mar 5.

    PMID: 32146259BACKGROUND

  • Alayed Y, Loblaw A, McGuffin M, Chung HT, Tseng CL, D'Alimonte L, Cheung P, Liu S, Chu W, Szumacher E, Helou J, Ravi A, Haider M, Mamedov A, Zhang L, Morton G. Single-fraction HDR brachytherapy as monotherapy in low and intermediate risk prostate cancer: Outcomes from two clinical trials with and without an MRI-guided boost. Radiother Oncol. 2021 Jan;154:29-35. doi: 10.1016/j.radonc.2020.09.007. Epub 2020 Sep 10.

    PMID: 32918971BACKGROUND

  • Corkum MT, Achard V, Morton G, Zilli T. Ultrahypofractionated Radiotherapy for Localised Prostate Cancer: How Far Can We Go? Clin Oncol (R Coll Radiol). 2022 May;34(5):340-349. doi: 10.1016/j.clon.2021.12.006. Epub 2021 Dec 25.

    PMID: 34961659BACKGROUND

  • Kukielka AM, Dabrowski T, Walasek T, Olchawa A, Kudzia R, Dybek D. High-dose-rate brachytherapy as a monotherapy for prostate cancer--Single-institution results of the extreme fractionation regimen. Brachytherapy. 2015 May-Jun;14(3):359-65. doi: 10.1016/j.brachy.2015.01.004. Epub 2015 Feb 28.

    PMID: 25736733BACKGROUND

Study Officials

  • I-Chow Hsu, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamese Johnson

CONTACT

415-530-9805Jamese.Johnson@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 27, 2022

Study Start

September 11, 2024

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)