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

NCT ID: NCT01868386

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2020-12-31

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.

Detailed Description

Primary Objectives:

To determine the shortest dose-fractionation schedule (Dose Schedule) with acceptable grade ¡Ã 3 GU/GI toxicity rate for salvage HypoFx RT to maintain a constant, high BED for prostate cancer response while reducing the BED for late GU and GI toxicity

To assess health-related quality of life (HRQOL) of the recommended Dose Schedule of salvage HypoFx RT by demonstrating no significant change in 1-year disease specific QoL, as compared to baseline

Secondary Objectives:

To evaluate and characterize the acute and late genitourinary (GU) and gastrointestinal (GI) adverse effects associated with postoperative, hypofractionated radiation therapy.

To evaluate biochemical failure rate, defined separately as nadir plus 2 ng/mL and as three consecutive rises in PSA, at 2 years after hypofractionated, post-prostatectomy radiation therapy.

To evaluate health utilities at 1 year after HypoFx salvage RT, as measured by the EQ-5D instrument.

To evaluate changes in sexual domain of EPIC quality of life instrument at 1 year after HypoFx salvage RT.

To evaluate the treatment burden for patients undergoing salvage HypoFx RT, in order to examine whether HypoFx RT results in less burdensome treatment for patients, as measured by patient-reported direct and indirect (i.e., transportation) health care costs and lost productivity due to treatment, as evaluated by the Work Productivity and Activity Impairment Questionnaire¢-General Health (WPAI-GH).

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Level 1

Hypofractionated therapy, 26 treatments at 2.5 Gy

Group Type: EXPERIMENTAL

Hypofractionated therapy

Intervention Type: RADIATION

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

Dose Level 2

Hypofractionated therapy, 20 treatments at 2.83Gy

Group Type: EXPERIMENTAL

Hypofractionated therapy

Intervention Type: RADIATION

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

Dose Level 3

Hypofractionated therapy,15 treatments at 3.36 Gy

Group Type: EXPERIMENTAL

Hypofractionated therapy

Intervention Type: RADIATION

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

Dose Level 4

Hypofractionated therapy, 10 treatments at 4.26 Gy

Group Type: EXPERIMENTAL

Hypofractionated therapy

Intervention Type: RADIATION

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

Interventions

Hypofractionated therapy

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

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Timothy Showalter, MD

OTHER

Sponsor Role: lead

Responsible Party

Timothy Showalter, MD

Professor, Radiation Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Timothy Showalter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia School of Medicine

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Southwest Virginia Regional Cancer Center

Norton, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33227441 (View on PubMed)

Other Identifiers

16604

Identifier Type: -

Identifier Source: org_study_id