High-Dose Brachytherapy in Treating Patients With Prostate Cancer

April 9, 2026 updated by: Stanford University

A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer

This trial studies the side effects and how well high-dose brachytherapy works in treating patients with prostate cancer that has not spread to other parts of the body. Brachytherapy is a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor and may be a better treatment in patients with prostate cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

To estimate the rate of acute (within 6 months of high-dose rate [HDR] completion) grade ≥ 2 genitourinary (GU) toxicity following high-dose-rate (HDR) brachytherapy (BT) as monotherapy for newly-diagnosed prostate cancer using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3 (CTCAE v3.0).

SECONDARY OBJECTIVES:

  • Estimate the proportion of men with a prostate-specific antigen (PSA) nadir by one year (nPSA12) of < 2 ng/mL.
  • Estimate the rate of freedom from biochemical failure at 5 years (FFBF).
  • Evaluate patient-reported quality of life via the 32-item Expanded Prostate Cancer Index Composite (EPIC).
  • Assess the cost-effectiveness of HDR BT as monotherapy for prostate cancer using the 6-item European Quality of Life 5-Dimensions (EQ-5D).
  • Explore pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer.
  • Compare acute and late (> 6 months after HDR completion) GU and gastrointestinal (GI) grade ≥ 2 toxicity using CTCAE v3.0 and v4.0.
  • Explore dosimetric predictors of toxicity.

Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients may receive androgen deprivation therapy (ADT) comprising bicalutamide orally (PO) once daily (QD). Patients may also receive luteinizing hormone-releasing hormone (LHRH) agonist therapy comprising leuprolide acetate intramuscularly (IM) or subcutaneously (SC), goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4 to 6 months (intermediate-risk patients receiving ADT) or 6 to 36 months (high-risk patients) at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and then yearly for up to 5 years.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented pathologic confirmation of prostate adenocarcinoma
  • Clinical T-classification T1-3
  • PSA < 150 ng/mL
  • Gleason score 6-10
  • Clinically negative lymph nodes as established by abdomino-pelvic CT. CT only for clinical classification of T3 (with contrast if renal function is acceptable; a non-contrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection. Patients with lymph nodes equivocal or questionable by imaging are eligible if those nodes are <1 cm in short axis diameter. [56]
  • No evidence of bone metastases (M0) on bone scan, only for PSA >20 ng/mLor Gleason ≥8, (NaF PET/CT is an acceptable substitute). Equivocal bone scan findings are allowed if plain films and/or MRI are negative for definite metastases.
  • American Urological Association Symptom Index (AUA SI) =< 20

Exclusion Criteria:

  • Clinical T4 disease
  • PSA >= 150 ng/mL
  • AUA SI > 20
  • History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for prostate cancer
  • Previous chemotherapy for any malignancy, if given within three years of registration
  • History of rectal surgery
  • History of rectal fistula
  • History of inflammatory bowel disease

  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last six months
    • Transmural myocardial infarction within the last six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Drug: Bicalutamide
Given PO
Other Names:
  • CDX
Drug: Goserelin Acetate
Given SC
Other Names:
  • ICI-118630
  • ZDX
  • Zoladex
Drug: Degarelix
Given SC
Other Names:
  • Firmagon
  • FE200486
Radiation: Internal Radiation Therapy
Undergo high-dose-rate brachytherapy
Other Names:
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy
  • Brachytherapy
Drug: Leuprolide Acetate
Given IM or SC
Other Names:
  • A-43818
Drug: Triptorelin Pamoate
Given IM
Other Names:
  • Trelstar
  • Pamorelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
Time Frame: Within 6 months of HDR completion
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Within 6 months of HDR completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of men with a nPSA12 of < 2 ng/mL
Time Frame: Up to 1 year after completion of HDR
nPSA12 is defined as the lowest PSA level achieved during the first year after completing HDR.
Up to 1 year after completion of HDR
FFBF (Biochemical failure define according to PSA nadir+2ng/mL and 3 consecutive rises definition according to American Society of Radiation Oncology
Time Frame: From the completion of all treatment to the time of BF, assessed at 5 years
Biochemical failure (BF) will be defined according the PSA nadir + 2 ng/mL and three consecutive rises definition according to the American Society of Radiation Oncology consensus recommendation. Time to first BF will be analyzed with competing risk models with death as a competing risk.
From the completion of all treatment to the time of BF, assessed at 5 years
Change in quality of life as measured by EPIC scores
Time Frame: Baseline to up to 5 years
Baseline to up to 5 years
Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores
Time Frame: Up to 5 years
Measured utility values for each patient on this study will be combined with overall survival to calculate the "QALY" quality-adjusted life years.
Up to 5 years
Pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer (association between each risk factor and the risk of having a first BF)
Time Frame: Baseline
Clinical risk factors will be tested in competing risk models to evaluate the association between each risk factor and the risk of having a first BF.
Baseline
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v4.0
Time Frame: Within 6 months of HDR completion
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Within 6 months of HDR completion
Late GU toxicity, scored according to CTCAE v3.0 and v4.0
Time Frame: Up to 5 years
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Up to 5 years
Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0
Time Frame: Up to 6 months after completing HDR BT
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Up to 6 months after completing HDR BT
Late GI toxicity, scored according to CTCAE v3.0 and CTCAE v4.0
Time Frame: Up to 5 years
Will be calculated with a 90% confidence interval. Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
Up to 5 years
Dosimetric predictors of toxicity (Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes)
Time Frame: Up to 5 years
Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mark Buyyounouski, Stanford University Hospitals and Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2015

Primary Completion (Actual)

December 14, 2021

Study Completion (Estimated)

May 17, 2026

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimated)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-32058
  • NCI-2015-00089 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • PROS0065 (Other Identifier: OnCore)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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