- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346253
High-Dose Brachytherapy in Treating Patients With Prostate Cancer
A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University, School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
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.
|
Correlative studies
Ancillary studies
Other Names:
Given PO
Other Names:
Given SC
Other Names:
Given SC
Other Names:
Undergo high-dose-rate brachytherapy
Other Names:
Given IM or SC
Other Names:
Given IM
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v3.0
Time Frame: Within 6 months of HDR completion
|
Will be calculated with a 90% confidence interval.
Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
|
Within 6 months of HDR completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of men with a nPSA12 of < 2 ng/mL
Time Frame: Up to 1 year after completion of HDR
|
nPSA12 is defined as the lowest PSA level achieved during the first year after completing HDR.
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Up to 1 year after completion of HDR
|
FFBF (Biochemical failure define according to PSA nadir+2ng/mL and 3 consecutive rises definition according to American Society of Radiation Oncology
Time Frame: From the completion of all treatment to the time of BF, assessed at 5 years
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Biochemical failure (BF) will be defined according the PSA nadir + 2 ng/mL and three consecutive rises definition according to the American Society of Radiation Oncology consensus recommendation.
Time to first BF will be analyzed with competing risk models with death as a competing risk.
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From the completion of all treatment to the time of BF, assessed at 5 years
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Change in quality of life as measured by EPIC scores
Time Frame: Baseline to up to 5 years
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Baseline to up to 5 years
|
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Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores
Time Frame: Up to 5 years
|
Measured utility values for each patient on this study will be combined with overall survival to calculate the "QALY" quality-adjusted life years.
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Up to 5 years
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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)
Time Frame: Baseline
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Clinical risk factors will be tested in competing risk models to evaluate the association between each risk factor and the risk of having a first BF.
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Baseline
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Proportion of patients with acute grade 2 or greater acute GU toxicity, scored according to CTCAE v4.0
Time Frame: Within 6 months of HDR completion
|
Will be calculated with a 90% confidence interval.
Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
|
Within 6 months of HDR completion
|
Late GU toxicity, scored according to CTCAE v3.0 and v4.0
Time Frame: Up to 5 years
|
Will be calculated with a 90% confidence interval.
Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
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Up to 5 years
|
Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0
Time Frame: Up to 6 months after completing HDR BT
|
Will be calculated with a 90% confidence interval.
Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
|
Up to 6 months after completing HDR BT
|
Late GI toxicity, scored according to CTCAE v3.0 and CTCAE v4.0
Time Frame: Up to 5 years
|
Will be calculated with a 90% confidence interval.
Treatment plans will be reviewed, and doses to normal structures will be calculated and tabulated to determine possible relationships with toxicity outcomes.
|
Up to 5 years
|
Dosimetric predictors of toxicity (Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes)
Time Frame: Up to 5 years
|
Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Buyyounouski, Stanford University Hospitals and Clinics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Fertility Agents, Female
- Fertility Agents
- Androgen Antagonists
- Luteolytic Agents
- Leuprolide
- Goserelin
- Bicalutamide
- Triptorelin Pamoate
Other Study ID Numbers
- IRB-32058
- NCI-2015-00089 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- PROS0065 (Other Identifier: OnCore)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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