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.
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
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.
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
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and
then yearly for up to 5 years.
- 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
- 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)
- 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
- 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
- Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C liver
- 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