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High-Dose Brachytherapy in Treating Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02346253
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer 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 Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 163 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer
Study Start Date : January 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in quality of life as measured by EPIC scores [ Time Frame: Baseline to up to 5 years ]
  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 skeletal system)
  • 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)

Exclusion Criteria:

  • 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 prostate cancer
  • 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 registration
    • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C liver disease
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346253


Contacts
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Contact: Matt Morales 650-721-4072 mmoral@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Matt Morales    650-721-4072    mmoral@stanford.edu   
Principal Investigator: Mark K. Buyyounouski         
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mark Buyyounouski Stanford University Hospitals and Clinics

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02346253     History of Changes
Other Study ID Numbers: PROS0065
NCI-2015-00089 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
40947 ( Other Identifier: Stanford IRB )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Leuprolide
Goserelin
Triptorelin Pamoate
Bicalutamide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents