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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stage II Prostate Adenocarcinoma Stage IIB Prostate Cancer Stage III Prostate Adenocarcinoma Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Radiation: Stereotactic Body Radiation Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose-Escalation Study of Hypofractionated SBRT for Adjuvant/Salvage Radiotherapy in Prostate Cancer
Actual Study Start Date : May 12, 2015
Estimated Primary Completion Date : May 12, 2020
Estimated Study Completion Date : May 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (hypofractionated SBRT)
Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446366


Locations
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United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Leslie Ballas University of Southern California
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02446366    
Other Study ID Numbers: 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 )
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type