High-Dose Brachytherapy in Treating Patients With Prostate Cancer

NCT02346253 | Active Not Recruiting DMC

• 3 other identifiers: IRB-32058NCI-2015-00089PROS0065
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IIA Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0

  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 Outcomes (10)

• Proportion of men with a nPSA12 of < 2 ng/mL

  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

  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

  Baseline to up to 5 years

• Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores

  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)

  Baseline

Study Arms (1)

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

EXPERIMENTAL

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.

Radiation: Internal Radiation Therapy; Drug: Bicalutamide; Drug: Leuprolide Acetate; Drug: Goserelin Acetate; Drug: Triptorelin Pamoate; Drug: Degarelix; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

Interventions

Leuprolide Acetate DRUG

Given IM or SC

Also known as: A-43818

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Internal Radiation Therapy RADIATION

Undergo high-dose-rate brachytherapy

Also known as: Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Degarelix DRUG

Given SC

Also known as: FE200486, Firmagon

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Bicalutamide DRUG

Given PO

Also known as: CDX

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Goserelin Acetate DRUG

Given SC

Also known as: ICI-118630, ZDX, Zoladex

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Triptorelin Pamoate DRUG

Given IM

Also known as: Pamorelin, Trelstar

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; bicalutamide; Leuprolide; Goserelin; Triptorelin Pamoate; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Mark Buyyounouski

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

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: January 20, 2015
• First Posted: January 26, 2015
• Study Start: January 13, 2015
• Primary Completion: December 14, 2021
• Study Completion (Estimated): May 17, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)