High-Dose Brachytherapy in Treating Patients with Prostate Cancer
- 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 abdominal-pelvic computed tomography (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
- No evidence of bone metastases (M0) on bone scan, only for PSA > 20 ng/mL or Gleason >= 8, (sodium fluoride [NaF] positron emission tomography [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
- Clinical T4
- 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
- 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
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).
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) & RedCap Digital EPIC Survey.
IV. To assess the cost-effectiveness of HDR BT as monotherapy for prostate cancer using the 6-item EuroQol European Quality of Life 5-Dimensions (EQ-5D) & RedCap Digital 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.
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 LHRH antagonist therapy comprising of degarelix SC for 4-36 months and 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.
Trial Phase Phase I/II
Trial Type Treatment
Stanford Cancer Institute Palo Alto
Mark K. Buyyounouski
- Primary ID PROS0065
- Secondary IDs NCI-2015-00089, 350
- Clinicaltrials.gov ID NCT02346253