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NCT02346253·Not applicable·INTERVENTIONAL

High-Dose Brachytherapy in Treating Patients With Prostate Cancer

DegarelixGoserelinTriptorelinLeuprolideOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

146

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

RADIATION

Internal Radiation Therapy

Undergo high-dose-rate brachytherapy

DRUG

Bicalutamide

Given PO

DRUG

Leuprolide Acetate

Given IM or SC

DRUG

Goserelin Acetate

Given SC

DRUG

Triptorelin Pamoate

Given IM

DRUG

Degarelix

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

Timeline

From registration to results.

  1. First posted

    Jan 26, 2015

  2. Study start

    Jan 13, 2015

  3. Primary completion

    Dec 14, 2021

  4. Study completion

    May 17, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 2, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

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.

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.

Change in Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Scores

Time frame · Baseline to up to 5 years

The Expanded Prostate Cancer Index Composite (EPIC) is a patient-reported health-related quality of life questionnaire that evaluates urinary, bowel, sexual, and hormonal function and bother among patients undergoing treatment for prostate cancer. Higher scores indicate better health-related quality of life within each domain.

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.

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.

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.

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.

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.

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.

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.

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Stanford University, School of Medicine

Stanford, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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