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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923506
Recruitment Status : Active, not recruiting
First Posted : August 15, 2013
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE August 13, 2013
First Posted Date  ICMJE August 15, 2013
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE November 25, 2013
Estimated Primary Completion Date June 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2013)
  • 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.
  • 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.
  • Biochemical progression-free survival [ Time Frame: Up to 3 years ]
    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 [ 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery
Official Title  ICMJE Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
Intervention  ICMJE
  • Radiation: stereotactic body radiation therapy
    Undergo SBRT
    Other Names:
    • SBRT
    • stereotactic radiation therapy
    • stereotactic radiotherapy
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (SBRT)
Patients receive 5 fractions of SBRT over 1.5 weeks.
Interventions:
  • Radiation: stereotactic body radiation therapy
  • Procedure: quality-of-life assessment
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2015)
28
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2013)
30
Estimated Study Completion Date  ICMJE June 25, 2021
Estimated Primary Completion Date June 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01923506
Other Study ID Numbers  ICMJE 13257
NCI-2013-01613 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
13257 ( Other Identifier: City of Hope Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sagus Sampath City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP