Clinical trial NCT01868386: Shorter Duration Radiotherapy to Treat Prostate Cancer After Removal of the Prostate
Official title: Hypofractionated Post-prostatectomy Radiotherapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Radiotherapy, hypofractionated
Salvage therapy
Radiotherapy, adjuvant
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: over a period of 2 years
measure: Quality of life measure
timeFrame: over a period of 2 years
Secondary outcomes:
measure: Biochemical failure rate
timeFrame: over a period of 2 years
Other outcomes:
measure: Acute and late GU and GI toxicity
timeFrame: over a period of two years
measure: Health Utilities
timeFrame: 1 year after radiation treatment
measure: EPIC Prostate Cancer-Specific QOL instrument
timeFrame: over a period of two years
measure: Ancillary financial burden
timeFrame: over a period of two years
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Norton
country: United States
facility: Southwest Virginia Regional Cancer Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: University of Virginia School of Medicine
name: Timothy Showalter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.