- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03541850
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the efficacy of postoperative stereotactic body radiation therapy (SBRT) at a dose of 34 grays (Gy) in five fractions, as compared with historical control efficacy rates in patients who received conventionally fractionated postoperative radiotherapy.
II. To determine the toxicity of postoperative SBRT at a dose of 34 Gy in five fractions, both via physician-scored and patient-reported metrics.
SECONDARY OBJECTIVES:
I. To determine the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with magnetic resonance imaging (MRI)-guided radiotherapy.
II. To gather biomarkers that may elucidate predictors of increased efficacy or increased toxicity.
TERTIARY OBJECTIVES:
I. To compare toxicity profiles (both physician-scored and patient-reported) between patients treated utilizing a linear accelerator versus a tri-60Co teletherapy platform.
OUTLINE:
Patients undergo SBRT every other day (QOD) for 14 days. Patients may also receive androgen deprivation therapy (ADT) comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.
After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
Los Angeles, California, United States, 90033
- USC Norris Comprehensive Cancer Center and Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
- Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
- Computed tomography (CT) scan and MRI of the pelvis within 120 days prior to enrollment (note: [a] if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed [b] for patients with PSA < 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan)
- Bone scan within 120 days prior to enrollment; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis, and advanced imaging (e.g., 18NaF positron emission tomography [PET]/CT) is strongly recommended
- Karnofsky performance score (KPS) >= 70
- Ability to understand, and willingness to sign, the written informed consent
Exclusion Criteria:
- Patients with any evidence of distant metastases
- Patients with pathologically-confirmed N1 prostate cancer
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate
- Prior pelvic radiotherapy
- History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
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 (SBRT, ADT)
Patients undergo SBRT QOD for 14 days.
Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.
|
Ancillary studies
Other Names:
Undergo SBRT
Other Names:
Receive luteinizing hormone-releasing hormone agonist or gonadotropin-releasing hormone antagonist, and oral anti-androgen
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical recurrence-free survival (BCRFS)
Time Frame: Up to 5 years
|
Defined as serum prostate-specific antigen (PSA) rising from the post-treatment nadir to a level of 0.4 ng/mL or more with a confirmatory second test, initiation of salvage androgen deprivation therapy, or continued rise in PSA after stereotactic body radiation therapy (SBRT).
The Kaplan-Meier product-limit estimate of the BCRFS will be estimated and presented graphically.
One sample log-rank test will be used to test difference in BCRFS between intervention and historical control.
The median BCRFS time will be calculated with 95% confidence interval.
Summaries of the number and percentage of patients experiencing a biochemical recurrence will be provided.
|
Up to 5 years
|
Physician-scored toxicity
Time Frame: Up to 5 years
|
Represented by the rates of acute (early, within 90 days of SBRT) and late (90 or more days after SBRT) genitourinary and gastrointestinal toxicity based on the Common Terminology Criteria for Adverse Events version 4.03.
Adverse Events (AEs) and serious adverse events (SAEs) will be listed individually by patient.
|
Up to 5 years
|
Patient-reported toxicity outcomes EPIC-26
Time Frame: Up to 5 years
|
Patient-reported toxicity outcomes represented by changes in the urinary incontinence, urinary obstruction, bowel, sexual function, and hormone/vitality domains on the Expanded Prostate Cancer Index-26 (EPIC-26) quality of life instrument (scored from 0-100 points for each domain, higher scores reflect worse symptom/bother severity.)
|
Up to 5 years
|
Patient-reported toxicity outcomes IPSS
Time Frame: Up to 5 years
|
Patient-reported toxicity outcomes represented by changes in International Prostate Symptom Scores (IPSS) (scored from 0-35 points, higher scores reflect worse symptom/bother severity.).
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of stereotactic body radiation therapy (SBRT) fractions for which on-line adaptive radiotherapy was utilized in the subset of patient treated with magnetic resonance imaging (MRI)-guided radiotherapy
Time Frame: Up to 5 years
|
Point estimate and the corresponding 95% confidence interval will be calculated for the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with MRI-guided radiotherapy.
|
Up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician-scored Toxicity profiles patients treated utilizing a linear accelerator
Time Frame: Up to 5 years
|
Comparative analysis will be performed to assess physician-scored toxicity profiles for treated utilizing a linear accelerator.
Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.
|
Up to 5 years
|
Patient-reported toxicity outcomes; patients treated utilizing a linear accelerator
Time Frame: Up to 5 years
|
Comparative analysis will be performed to assess patient-reported toxicity profiles for treated utilizing a linear accelerator.
Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.
|
Up to 5 years
|
Physician-scored toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device
Time Frame: Up to 5 years
|
Comparative analysis will be performed to assess toxicity profiles with patients treated utilizing a linear accelerator.
Chi-square test or Fisher's exact test will be used for qualitative toxicity measurements, while unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.
|
Up to 5 years
|
Patient-reported toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device
Time Frame: Up to 5 years
|
Comparative analysis will be performed to assess patient-reported toxicity profiles for treated utilizing an MRI-guided radiotherapy device.
Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amar Kishan, MD, UCLA / Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Male
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protective Agents
- Estrogens
- Micronutrients
- Hormone Antagonists
- Vitamins
- Antioxidants
- Anabolic Agents
- Hormones
- Ascorbic Acid
- Androgens
- Methyltestosterone
- Estrogens, Conjugated (USP)
- Androgen Antagonists
Other Study ID Numbers
- 17-001064
- NCI-2017-02032 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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