Stanford, California 94305


Purpose:

This phase I/II 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 summary:

PRIMARY OBJECTIVES: I. To estimate the rate of acute (within six 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: I. To estimate the proportion of men with a prostate-specific antigen (PSA) nadir by one year (nPSA12) of < 2 ng/mL. II. To estimate the rate of freedom from biochemical failure at 5 years (FFBF). III. To evaluate patient-reported quality of life via the 32-item Expanded Prostate Cancer Index Composite (EPIC). IV. To assess the cost-effectiveness of HDR BT as monotherapy for prostate cancer using the 6-item European Quality of Life 5-Dimensions (EQ-5D). V. To explore pre-treatment clinical risk factors to optimize patient selection for HDR BT as monotherapy for prostate cancer. VI. To compare acute and late (> 6 months after HDR completion) GU and gastrointestinal (GI) grade >= 2 toxicity using CTCAE v3.0 and v4.0. VII. To explore dosimetric predictors of toxicity. OUTLINE: 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 4-6 months (intermediate-risk patients receiving ADT) or 6-36 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.


Criteria:

Inclusion Criteria: - Documented pathologic confirmation of prostate adenocarcinoma - Clinical T-classification T1-3 - PSA < 150 ng/mL - Gleason score 6-10 - No evidence of distant metastasis based on a history/physical examination (to include at least digital rectal examination of the prostate and assessment of the abdomen and skeletal system) - Clinically negative lymph nodes as established by abdomino-pelvic CT, no more than 90 days prior toregistration; 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) or magnetic resonance imaging (MRI), nodal sampling, or dissection. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are <1 cm in short axis. - No evidence of bone metastases (M0) on bone scan (sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute) performed no more than 120 days prior to registration; equivocal bone scan findings are allowed if plain films and/or MRI are negative for definite metastases - American Urological Association Symptom Index (AUA SI) =< 15 - No prior transurethral resection of prostate (TURP) Exclusion Criteria: - Clinical T4 disease - N1 patients are ineligible, as are those with pelvic lymph nodes >= 1 cm in short axis diameter, defined as pathologically enlarged per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, by CT or MRI of the abdomen and pelvis, unless the enlarged lymph nodes are negative after sampling - PSA >= 150 ng/mL - AUA SI > 15 - History of radical prostatectomy, external beam radiotherapy (EBRT), or BT for prostate cancer - Prior invasive malignancy (except non-melanoma skin cancer), unless disease-free for at least 3 years; no patient with a history of pelvic or hematologic malignancy is eligible, regardless of disease-free interval - Previous chemotherapy for any malignancy, if given within three years of registration - Past history of other investigational agents - 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 - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration - Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C liver disease - Human immunodeficiency virus (HIV)-positivity with cluster of differentiation (CD)4 count < 200 cells/microliter; note that HIV-positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter no more than 30 days prior to registration; note also that HIV testing is not required for eligibility on this protocol - End-stage renal disease (i.e., any patient requiring or advised to undergo dialysis) - Prior allergic reaction to the study drug(s) involved in this protocol


NCT ID:

NCT02346253


Primary Contact:

Principal Investigator
Mark Buyyounouski
Stanford University Hospitals and Clinics

Madelyn Kissel
Phone: 650-497-8966
Email: mkissel@stanford.edu


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States

Madelyn Kissel
Phone: 650-497-8966
Email: mkissel@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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