Shorter Duration Radiotherapy to Treat Prostate Cancer After Removal of the Prostate (HypoFX)

• ClinicalTrials.gov Identifier: NCT01868386
• Recruitment Status: Active, not recruiting
• First Posted: June 4, 2013
• Last Update Posted: November 25, 2019
• Sponsor: Timothy Showalter, MD
• Information provided by (Responsible Party): Timothy Showalter, MD, University of Virginia

Study Description

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

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).

Study Design

• 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

Arms and Interventions

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

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

• 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

Locations

United States, Virginia

University of Virginia Health System

Charlottesville, Virginia, United States, 22908

Southwest Virginia Regional Cancer Center

Norton, Virginia, United States, 24273

Virginia Commonwealth University

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

• Responsible Party: Timothy Showalter, MD, Assistant Professor, Radiation Oncology, University of Virginia
• ClinicalTrials.gov Identifier: NCT01868386
• Other Study ID Numbers: 16604
• First Posted: June 4, 2013
• Last Update Posted: November 25, 2019
• Last Verified: November 2019

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