ClinicalTrials.gov
ClinicalTrials.gov Menu

Shorter Duration Radiotherapy to Treat Prostate Cancer After Removal of the Prostate

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01868386
Recruitment Status : Recruiting
First Posted : June 4, 2013
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Showalter, MD, University of Virginia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after surgery. When radiation therapy is given to patients who have an increase in PSA after surgery, it is called "salvage radiation therapy". Currently the standard radiation therapy course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy after prostate removal causes unpleasant side effects. A shorter course of radiation therapy, known as a "hypofractionated" course, gives fewer but higher doses of radiation than standard radiation.

The purpose of this study is to test the safety of a shorter course of radiation therapy at progressively lower dose levels and shorter lengths of treatment (hypofractionated) with patients who have had their prostate removed. The study will assess whether the hypofractionated course works better without causing additional side effects to the remaining cancer cells in the prostate bed.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Hypofractionated therapy Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Post-prostatectomy Radiotherapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase I/II Trial
Study Start Date : April 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dose Level 1
Hypofractionated therapy, 26 treatments at 2.5 Gy
 Radiation: Hypofractionated therapy
Shorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm
Experimental: Dose Level 2
Hypofractionated therapy, 20 treatments at 2.83Gy
 Radiation: Hypofractionated therapy
Shorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm
Experimental: Dose Level 3
Hypofractionated therapy,15 treatments at 3.36 Gy
 Radiation: Hypofractionated therapy
Shorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm
Experimental: Dose Level 4
Hypofractionated therapy, 10 treatments at 4.26 Gy
 Radiation: Hypofractionated therapy
Shorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Dose limiting toxicity [ Time Frame: over a period of 2 years ]
    Incidence of GU (genitourinary) and GI (gastrointestinal) toxicities of CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or greater

  2. Quality of life measure [ Time Frame: over a period of 2 years ]
    To compare quality of life post-procedure from baseline


Secondary Outcome Measures :
  1. Biochemical failure rate [ Time Frame: over a period of 2 years ]
    A biochemical failure is defined as an increase in prostate serum antigen concentration to nadir plus 2ng/mL or 3 consecutive increases in PSA


Other Outcome Measures:
  1. Acute and late GU and GI toxicity [ Time Frame: over a period of two years ]
  2. Health Utilities [ Time Frame: 1 year after radiation treatment ]
  3. EPIC Prostate Cancer-Specific QOL instrument [ Time Frame: over a period of two years ]
    looking at changes in sexual and hormonal domains

  4. Ancillary financial burden [ Time Frame: over a period of two years ]
    estimating out-of-pocket costs and lost wages for patients during treatment


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • diagnosis of prostate adenocarcinoma and
  • have had a prostatectomy
  • have detectable PSA
  • 18 years of age or older

Exclusion Criteria:

  • are receiving chemotherapy or other agents intended for cancer treatment
  • history of rectal surgery or lower gastrointestinal bleed
  • history of bleeding diathesis or abnormal sensitivity to ionizing radiation
  • had prior pelvic irradiation or are scheduled to receive pelvic nodal irradiation
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01868386


Contacts
Contact: Amy K Camblos 434-243-1927 amycamblos@virginia.edu

Locations
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Timothy Showalter, MD         
Principal Investigator: Timothy Showalter, MD         
Southwest Virginia Regional Cancer Center Recruiting
Norton, Virginia, United States, 24273
Contact: Missy Mullins, RN, BSN, OCN    276-679-5874    Melissa.mullins@wellmont.org   
Virginia Commonwealth University Completed
Richmond, Virginia, United States, 23220
Sponsors and Collaborators
Timothy Showalter, MD
Investigators
Principal Investigator: Timothy Showalter, MD University of Virginia School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Timothy Showalter, MD, Assistant Professor, Radiation Oncology, University of Virginia
ClinicalTrials.gov Identifier: NCT01868386     History of Changes
Other Study ID Numbers: 16604
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Keywords provided by Timothy Showalter, MD, University of Virginia:
Radiotherapy, hypofractionated
Salvage therapy
Radiotherapy, adjuvant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases