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Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery

Primary Purpose

Stage II Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Adenocarcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Stereotactic Body Radiation Therapy
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II Prostate Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Adenocarcinoma of the prostate treated primarily with radical prostatectomy

    • Any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy

  • One of the following pathologic classifications

    • T3N0 disease with or without a positive surgical margin or

    • T2N0 disease with or without a positive surgical margin

      • Those with T2N0 disease and a negative margin must have a detectable prostate-specific antigen (PSA) following radical prostatectomy or
      • Must have had an undetectable PSA after prostatectomy and has since had a rise in post-operative PSA to 0.2 ng/mL or greater
  • Zubrod performance status of 0 -1

  • No distant metastases, based on the following workup within 60 days prior to registration

    • Magnetic resonance imaging (MRI) of the pelvis
    • Bone scan or sodium fluoride positron emission tomography (PET), that if suspicious has MRI or plain X-rays to rule out bone metastasis
  • Patients can be on androgen deprivation therapy
  • Ability to understand and willingness to sign a study-specific informed consent prior to study entry

Exclusion Criteria:

  • N1 patients are ineligible, as are those with lymph node (LN) enlargement > 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative
  • Gross residual disease in the prostate fossa appreciated wither on digital rectal examination (DRE) or on imaging, unless biopsy proven not to contain cancer
  • Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy

  • Prior radiation of any kind to the prostate gland or pelvis

    • Prior brachytherapy is not allowed
  • History of inflammatory colitis or other active severe comorbidities
  • Patients who are on immunosuppressant medication

Sites / Locations

  • USC Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (hypofractionated SBRT)

Arm Description

Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.

Outcomes

Primary Outcome Measures

Maximum tolerated dose-per-fraction based on acute toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced dose limiting toxicity (DLT) attributable to the radiation therapy when 12 patients were treated at that dose and are evaluable for toxicity and is one dose level below the lowest dose level tested where two or more patients experienced radiation associated DLT. All toxicities and side effects of all patients who start SBRT will be recorded and summarized.

Secondary Outcome Measures

Incidence of adverse events assessed according to CTCAE v. 4.03
All toxicities and side effects of all patients who start SBRT will be recorded and summarized.

Full Information

First Posted
April 10, 2015
Last Updated
December 8, 2022
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02446366
Brief Title
Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery
Official Title
Phase I Dose-Escalation Study of Hypofractionated SBRT for Adjuvant/Salvage Radiotherapy in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2015 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
This phase I trial studies the side effects and the best dose of hypofractionated stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and may have fewer side effects than standard radiation therapy.
Detailed Description
PRIMARY OBJECTIVES: I. To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following prostatectomy based on acute toxicity (< 90 days). SECONDARY OBJECTIVES: I. To describe the acute (< 90 days) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting. II. To describe the late (> 90 days from treatment) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting. TERTIARY OBJECTIVES: I. To describe the patient-reported toxicity/quality of life (QOL) following hypofractionated SBRT treatment. OUTLINE: This is a dose-escalation study. Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks. After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then at 6, 9, 12, 18, 24, 30 and 36 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (hypofractionated SBRT)
Arm Type
Experimental
Arm Description
Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
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)
SBRT
Intervention Description
Undergo hypofractionated SBRT
Primary Outcome Measure Information:
Title
Maximum tolerated dose-per-fraction based on acute toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Description
Maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced dose limiting toxicity (DLT) attributable to the radiation therapy when 12 patients were treated at that dose and are evaluable for toxicity and is one dose level below the lowest dose level tested where two or more patients experienced radiation associated DLT. All toxicities and side effects of all patients who start SBRT will be recorded and summarized.
Time Frame
< 90 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events assessed according to CTCAE v. 4.03
Description
All toxicities and side effects of all patients who start SBRT will be recorded and summarized.
Time Frame
Up to 36 months after completion of SBRT

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adenocarcinoma of the prostate treated primarily with radical prostatectomy Any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy One of the following pathologic classifications T3N0 disease with or without a positive surgical margin or T2N0 disease with or without a positive surgical margin Those with T2N0 disease and a negative margin must have a detectable prostate-specific antigen (PSA) following radical prostatectomy or Must have had an undetectable PSA after prostatectomy and has since had a rise in post-operative PSA to 0.2 ng/mL or greater Zubrod performance status of 0 -1 No distant metastases, based on the following workup within 60 days prior to registration Magnetic resonance imaging (MRI) of the pelvis Bone scan or sodium fluoride positron emission tomography (PET), that if suspicious has MRI or plain X-rays to rule out bone metastasis Patients can be on androgen deprivation therapy Ability to understand and willingness to sign a study-specific informed consent prior to study entry Exclusion Criteria: N1 patients are ineligible, as are those with lymph node (LN) enlargement > 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative Gross residual disease in the prostate fossa appreciated wither on digital rectal examination (DRE) or on imaging, unless biopsy proven not to contain cancer Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy Prior radiation of any kind to the prostate gland or pelvis Prior brachytherapy is not allowed History of inflammatory colitis or other active severe comorbidities Patients who are on immunosuppressant medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Ballas
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30605751
Citation
Ballas LK, Luo C, Chung E, Kishan AU, Shuryak I, Quinn DI, Dorff T, Jhimlee S, Chiu R, Abreu A, Jennelle R, Aron M, Groshen S. Phase 1 Trial of SBRT to the Prostate Fossa After Prostatectomy. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):50-60. doi: 10.1016/j.ijrobp.2018.12.047. Epub 2018 Dec 31.
Results Reference
derived

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Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery

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