High-Dose Brachytherapy in Treating Patients With Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT02346253 |
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Recruitment Status :
Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : September 9, 2022
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Sponsor:
Stanford University
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University
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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.
| 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 | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 163 participants |
| Allocation: | N/A |
| 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 |
| Actual Study Start Date : | January 13, 2015 |
| Actual Primary Completion Date : | December 14, 2021 |
| Estimated Study Completion Date : | December 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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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.
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Radiation: Internal Radiation Therapy
Undergo high-dose-rate brachytherapy
Other Names:
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:
Drug: Triptorelin Pamoate Given IM
Other Names:
Drug: Degarelix Given SC
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
Primary Outcome Measures :
- 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 :
- 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.
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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
- 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
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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
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
Locations
| United States, California | |
| Stanford University, School of Medicine | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Mark Buyyounouski | Stanford University Hospitals and Clinics |
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT02346253 |
| Other Study ID Numbers: |
IRB-32058 NCI-2015-00089 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) PROS0065 ( Other Identifier: OnCore ) |
| First Posted: | January 26, 2015 Key Record Dates |
| Last Update Posted: | September 9, 2022 |
| Last Verified: | September 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases 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 Contraceptive Agents, Hormonal |