COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by 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: NCT02446366
Recruitment Status : Active, not recruiting
First Posted : May 18, 2015
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE April 10, 2015
First Posted Date  ICMJE May 18, 2015
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE May 12, 2015
Estimated Primary Completion Date May 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
Maximum tolerated dose-per-fraction based on acute toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 [ Time Frame: < 90 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
Incidence of adverse events assessed according to CTCAE v. 4.03 [ Time Frame: Up to 36 months after completion of SBRT ]
All toxicities and side effects of all patients who start SBRT will be recorded and summarized.
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 Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery
Official Title  ICMJE Phase I Dose-Escalation Study of Hypofractionated SBRT for Adjuvant/Salvage Radiotherapy in Prostate Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage II Prostate Adenocarcinoma
  • Stage IIB Prostate Cancer
  • Stage III Prostate Adenocarcinoma
Intervention  ICMJE
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Radiation: Stereotactic Body Radiation Therapy
    Undergo hypofractionated SBRT
    Other Name: SBRT
Study Arms  ICMJE Experimental: Treatment (hypofractionated SBRT)
Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.
Interventions:
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment
  • Radiation: Stereotactic Body Radiation Therapy
Publications * 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.

*   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: May 13, 2015)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 12, 2021
Estimated Primary Completion Date May 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 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 NCT02446366
Other Study ID Numbers  ICMJE 4P-14-8
NCI-2015-00296 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4P-14-8 ( Other Identifier: USC Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Leslie Ballas University of Southern California
PRS Account University of Southern California
Verification Date May 2019

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