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History of Changes for Study: NCT01923506
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery
Latest version (submitted November 22, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 13, 2013 None (earliest Version on record)
2 October 23, 2013 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 November 5, 2013 Study Status
4 January 24, 2014 Study Status, Eligibility and Study Description
5 June 12, 2014 Study Status, Eligibility and Study Identification
6 November 25, 2014 Study Status and Study Description
7 April 24, 2015 Study Status and Eligibility
8 August 26, 2015 Study Status and Study Design
9 February 15, 2016 Study Status
10 August 16, 2016 Study Status
11 February 16, 2017 Study Status
12 August 16, 2017 Study Status
13 January 10, 2018 Recruitment Status, Study Status and Contacts/Locations
14 June 27, 2018 Study Status
15 December 27, 2018 Study Status
16 November 5, 2019 Study Status
17 January 3, 2020 Study Status
18 December 15, 2020 Study Status
19 September 21, 2021 Study Status and Study Design
20 November 22, 2022 Study Status
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Study NCT01923506
Submitted Date:  August 13, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 13257
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
Secondary IDs: NCI-2013-01613 [Registry Identifier: CTRP (Clinical Trial Reporting Program)]
13257 [City of Hope Medical Center]
P30CA033572 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: August 2013
Overall Status: Not yet recruiting
Study Start: October 2013
Primary Completion: October 2015 [Anticipated]
Study Completion:
First Submitted: August 13, 2013
First Submitted that
Met QC Criteria:
August 13, 2013
First Posted: August 15, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 13, 2013
Last Update Posted: August 15, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: City of Hope Medical Center
Responsible Party: Sponsor
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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 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.

Open or close this module Conditions
Conditions: Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment (SBRT)
Patients receive 5 fractions of SBRT over 1.5 weeks.
Radiation: stereotactic body radiation therapy
Undergo SBRT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
laboratory biomarker analysis
Correlative studies
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
[ Time Frame: 90 days ]

Tables will be created to summarize these toxicities and side effects by dose level.
Secondary Outcome Measures:
1. Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
[ Time Frame: Up to 90 days ]

Tables will be created to summarize these toxicities and side effects by dose level.
2. Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
[ Time Frame: Up to 3 years ]

Tables will be created to summarize these toxicities and side effects by dose level.
3. Biochemical progression-free survival
[ Time Frame: Up to 3 years ]

Estimated using Kaplan-Meier. 95% confidence intervals should be provided.
4. Prospective quality-of-life data related to bowel, urinary, and sexual health using the numerical scores generated from the patient questionnaires
[ Time Frame: Up to 3 years ]

Quality of life questionnaires include the International Prostate Symptom Scale (IPSS), sexual health inventory for men (SHIM), and Merrick rectal function scale.
Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
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 60 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
  • 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:
    • Administration of leuteinizing-hormone releasing-hormone agonist or antagonist, or testosterone-receptor blocker within the past 6 months prior to study registration
    • 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
Open or close this module Contacts/Locations
Study Officials: Sagus Sampath
Principal Investigator
City of Hope Medical Center
Locations: United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Contact:Contact: Sagus Sampath 800-826-4673 ssampath@coh.org
Contact:Principal Investigator: Sagus Sampath
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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