High-Dose Brachytherapy in Treating Patients With Prostate Cancer

Stanford University

Status

Active, not recruiting

Conditions

Prostate Adenocarcinoma

Stage I Prostate Cancer

Stage IIA Prostate Cancer

Stage III Prostate Cancer

Stage IIB Prostate Cancer

Treatments

Drug: Goserelin Acetate

Drug: Bicalutamide

Radiation: Internal Radiation Therapy

Drug: Leuprolide Acetate

Other: Quality-of-Life Assessment

Other: Laboratory Biomarker Analysis

Drug: Degarelix

Drug: Triptorelin Pamoate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02346253

NCI-2015-00089 (Registry Identifier)

PROS0065 (Other Identifier)

IRB-32058

Details and patient eligibility

About

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 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.

Enrollment

146 patients

Sex

Male

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

146 participants in 1 patient group

Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)

Experimental group

Description:

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.

Treatment: