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High-Dose Brachytherapy in Treating Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02346253
Recruitment Status : Suspended (Logistics)
First Posted : January 26, 2015
Last Update Posted : August 4, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE January 20, 2015
First Posted Date  ICMJE January 26, 2015
Last Update Posted Date August 4, 2021
Actual Study Start Date  ICMJE January 13, 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
  • 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.
  • 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 ]
    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.
  • Change in quality of life as measured by EPIC scores [ Time Frame: Baseline to up to 5 years ]
  • 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.
  • 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 ]
    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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Dose Brachytherapy in Treating Patients With Prostate Cancer
Official Title  ICMJE A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Adenocarcinoma
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
Intervention  ICMJE
  • Radiation: Internal Radiation Therapy
    Undergo high-dose-rate brachytherapy
    Other Names:
    • Brachytherapy
    • Internal Radiation
    • Internal Radiation Brachytherapy
    • Radiation Brachytherapy
  • Drug: Bicalutamide
    Given PO
    Other Name: CDX
  • Drug: Leuprolide Acetate
    Given IM or SC
    Other Name: A-43818
  • Drug: Goserelin Acetate
    Given SC
    Other Names:
    • ICI-118630
    • ZDX
    • Zoladex
  • Drug: Triptorelin Pamoate
    Given IM
    Other Names:
    • Pamorelin
    • Trelstar
  • Drug: Degarelix
    Given SC
    Other Names:
    • FE200486
    • Firmagon
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
Study Arms  ICMJE 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.
Interventions:
  • Radiation: Internal Radiation Therapy
  • Drug: Bicalutamide
  • Drug: Leuprolide Acetate
  • Drug: Goserelin Acetate
  • Drug: Triptorelin Pamoate
  • Drug: Degarelix
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 23, 2015)
163
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02346253
Other Study ID Numbers  ICMJE IRB-32058
NCI-2015-00089 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PROS0065 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mark Buyyounouski Stanford University Hospitals and Clinics
PRS Account Stanford University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP