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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01923506
Collaborator
National Cancer Institute (NCI) (NIH)
26
Enrollment
1
Location
1
Arm
103
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: stereotactic body radiation therapy
  • Procedure: quality-of-life assessment
  • Other: laboratory biomarker analysis
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

  1. To assess acute and late toxicities from treatment.

  2. To assess biochemical progression-free survival.

  3. 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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study
Actual Study Start Date :
Nov 25, 2013
Actual Primary Completion Date :
Jan 23, 2018
Anticipated Study Completion Date :
Jun 25, 2022

Arms and Interventions

Arm Intervention/Treatment
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

    • Other: laboratory biomarker analysis
    Correlative studies

    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 [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 [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 [Up to 3 years]

      Tables will be created to summarize these toxicities and side effects by dose level.

    3. Biochemical progression-free survival [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Sagus Sampath, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT01923506
    Other Study ID Numbers:
    • 13257
    • NCI-2013-01613
    • 13257
    First Posted:
    Aug 15, 2013
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Sep 23, 2021