NCT01868386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_1 prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

7.7 years

First QC Date

May 14, 2013

Last Update Submit

April 26, 2021

Conditions

Prostate Cancer

Keywords

Radiotherapy, hypofractionatedSalvage therapyRadiotherapy, adjuvant

Outcome Measures

Primary Outcomes (2)

  • Dose limiting toxicity

    Incidence of GU (genitourinary) and GI (gastrointestinal) toxicities of CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or greater

    over a period of 2 years

  • Quality of life measure

    To compare quality of life post-procedure from baseline

    over a period of 2 years

Secondary Outcomes (1)

  • Biochemical failure rate

    over a period of 2 years

Other Outcomes (4)

  • Acute and late GU and GI toxicity

    over a period of two years

  • Health Utilities

    1 year after radiation treatment

  • EPIC Prostate Cancer-Specific QOL instrument

    over a period of two years

  • +1 more other outcomes

Study Arms (4)

Dose Level 1

EXPERIMENTAL

Hypofractionated therapy, 26 treatments at 2.5 Gy

Radiation: Hypofractionated therapy

Dose Level 2

EXPERIMENTAL

Hypofractionated therapy, 20 treatments at 2.83Gy

Radiation: Hypofractionated therapy

Dose Level 3

EXPERIMENTAL

Hypofractionated therapy,15 treatments at 3.36 Gy

Radiation: Hypofractionated therapy

Dose Level 4

EXPERIMENTAL

Hypofractionated therapy, 10 treatments at 4.26 Gy

Radiation: Hypofractionated therapy

Interventions

Hypofractionated therapyRADIATION

Shorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm

Dose Level 1Dose Level 2Dose Level 3Dose Level 4

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Southwest Virginia Regional Cancer Center

Norton, Virginia, 24273, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23220, United States

Location

Related Publications (1)

  • Wages NA, Sanders JC, Smith A, Wood S, Anscher MS, Varhegyi N, Krupski TL, Harris TJ, Showalter TN. Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1254-1262. doi: 10.1016/j.ijrobp.2020.11.009. Epub 2020 Nov 21.

    PMID: 33227441BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Timothy Showalter, MD

    University of Virginia School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Radiation Oncology

Study Record Dates

First Submitted

May 14, 2013

First Posted

June 4, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

US(3)