Clinical trial NCT02346253: High-Dose Brachytherapy in Treating Patients With Prostate Cancer
Official title: A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 146
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
timeFrame: Within 6 months of HDR completion
Secondary outcomes:
measure: Proportion of men with a nPSA12 of < 2 ng/mL
timeFrame: Up to 1 year after completion of HDR
measure: FFBF (Biochemical failure define according to PSA nadir+2ng/mL and 3 consecutive rises definition according to American Society of Radiation Oncology
timeFrame: From the completion of all treatment to the time of BF, assessed at 5 years
measure: Change in quality of life as measured by EPIC scores
timeFrame: Baseline to up to 5 years
measure: Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores
timeFrame: Up to 5 years
measure: 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)
timeFrame: Baseline
measure: Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v4.0
timeFrame: Within 6 months of HDR completion
measure: Late GU toxicity, scored according to CTCAE v3.0 and v4.0
timeFrame: Up to 5 years
measure: Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0
timeFrame: Up to 6 months after completing HDR BT
measure: Late GI toxicity, scored according to CTCAE v3.0 and CTCAE v4.0
timeFrame: Up to 5 years
measure: Dosimetric predictors of toxicity (Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Mark Buyyounouski
role: PRINCIPAL_INVESTIGATOR
References: