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Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery

Primary Purpose

Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
stereotactic body radiation therapy
quality-of-life assessment
laboratory biomarker analysis
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • History of diagnosis of prostate cancer after undergoing prostatectomy
  • No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic
  • Eastern Cooperative Oncology Group (ECOG) performance scale 0-2
  • Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable
  • Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry
  • PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion
  • All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients should not have any uncontrolled illness including ongoing or active infection
  • Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy
  • Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years

  • Study-specific exclusions:

    • History of prior radiation to the pelvis
    • History of uncontrolled inflammatory bowel disease
    • Unable to comply with radiation therapy procedures
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SBRT)

Arm Description

Patients receive 5 fractions of SBRT over 1.5 weeks.

Outcomes

Primary Outcome Measures

MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.

Secondary Outcome Measures

Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.
Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.
Biochemical progression-free survival
Estimated using Kaplan-Meier. 95% confidence intervals should be provided.
Prospective quality-of-life data related to bowel, urinary, and sexual health using the numerical scores generated from the patient questionnaires
Quality of life questionnaires include the International Prostate Symptom Scale (IPSS), sexual health inventory for men (SHIM), and Merrick rectal function scale.

Full Information

First Posted
August 13, 2013
Last Updated
March 1, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01923506
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery
Official Title
Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 25, 2013 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) with an upper limit of 45 Gray (Gy) in 5 fractions, in the delivery of stereotactic body radiation therapy (SBRT) to the prostate fossa. SECONDARY OBJECTIVES: I. To assess acute and late toxicities from treatment. II. To assess biochemical progression-free survival. III. To collect prospective quality-of-life data related to bowel, urinary, and sexual health. OUTLINE: This is a dose-escalation study. Patients receive 5 fractions of SBRT over 1.5 weeks. After completion of study treatment, patients are followed up at 90 days and then periodically for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (SBRT)
Arm Type
Experimental
Arm Description
Patients receive 5 fractions of SBRT over 1.5 weeks.
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy
Other Intervention Name(s)
SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Intervention Description
Undergo SBRT
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Description
Tables will be created to summarize these toxicities and side effects by dose level.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Description
Tables will be created to summarize these toxicities and side effects by dose level.
Time Frame
Up to 90 days
Title
Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Description
Tables will be created to summarize these toxicities and side effects by dose level.
Time Frame
Up to 3 years
Title
Biochemical progression-free survival
Description
Estimated using Kaplan-Meier. 95% confidence intervals should be provided.
Time Frame
Up to 3 years
Title
Prospective quality-of-life data related to bowel, urinary, and sexual health using the numerical scores generated from the patient questionnaires
Description
Quality of life questionnaires include the International Prostate Symptom Scale (IPSS), sexual health inventory for men (SHIM), and Merrick rectal function scale.
Time Frame
Up to 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of diagnosis of prostate cancer after undergoing prostatectomy No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic Eastern Cooperative Oncology Group (ECOG) performance scale 0-2 Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Patients should not have any uncontrolled illness including ongoing or active infection Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years Study-specific exclusions: History of prior radiation to the pelvis History of uncontrolled inflammatory bowel disease Unable to comply with radiation therapy procedures Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sagus Sampath
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery

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