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Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Active Not Recruiting NA INTERVENTIONAL NCT02346253

High-Dose Brachytherapy in Treating Patients With Prostate Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

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.

Interventions

Name: Internal Radiation Therapy
Type: RADIATION
Description: Undergo high-dose-rate brachytherapy
Name: Bicalutamide
Type: DRUG
Description: Given PO
Name: Leuprolide Acetate
Type: DRUG
Description: Given IM or SC
Name: Goserelin Acetate
Type: DRUG
Description: Given SC
Name: Triptorelin Pamoate
Type: DRUG
Description: Given IM
Name: Degarelix
Type: DRUG
Description: Given SC
Name: Laboratory Biomarker Analysis
Type: OTHER
Description: Correlative studies
Name: Quality-of-Life Assessment
Type: OTHER
Description: Ancillary studies

Primary Outcomes

Measure: Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
TimeFrame: Within 6 months of HDR completion
Description: 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.

Trial Information

NCT ID

NCT02346253

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Stanford University

Last Updated

December 15, 2025