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Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

Primary Purpose

PSA Level Greater Than 0.03, PSA Progression, Stage I Prostate Adenocarcinoma AJCC (American Joint Committee on Cancer ) v7

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antiandrogen Therapy
Quality-of-Life Assessment
Stereotactic Body Radiation Therapy
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PSA Level Greater Than 0.03

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • USC Norris Comprehensive Cancer Center and Hospital
  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SBRT, ADT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Biochemical recurrence-free survival (BCRFS)
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.
Physician-scored toxicity
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.
Patient-reported toxicity outcomes EPIC-26
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.)
Patient-reported toxicity outcomes IPSS
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.).

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 9, 2018
Last Updated
January 5, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Viewray Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03541850
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
Official Title
Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Viewray Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PSA Level Greater Than 0.03, PSA Progression, Stage I Prostate Adenocarcinoma AJCC (American Joint Committee on Cancer ) v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (SBRT, ADT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Antiandrogen Therapy
Other Intervention Name(s)
ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy
Intervention Description
Receive luteinizing hormone-releasing hormone agonist or gonadotropin-releasing hormone antagonist, and oral anti-androgen
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Biochemical recurrence-free survival (BCRFS)
Description
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.
Time Frame
Up to 5 years
Title
Physician-scored toxicity
Description
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.
Time Frame
Up to 5 years
Title
Patient-reported toxicity outcomes EPIC-26
Description
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.)
Time Frame
Up to 5 years
Title
Patient-reported toxicity outcomes IPSS
Description
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.).
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
Physician-scored Toxicity profiles patients treated utilizing a linear accelerator
Description
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.
Time Frame
Up to 5 years
Title
Patient-reported toxicity outcomes; patients treated utilizing a linear accelerator
Description
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.
Time Frame
Up to 5 years
Title
Physician-scored toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device
Description
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.
Time Frame
Up to 5 years
Title
Patient-reported toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amar Kishan, MD
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

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