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

Prostate Cancer Clinical Trial

— HypoFX  

Official title:

Hypofractionated Post-prostatectomy Radiotherapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase I/II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868386
• Other study ID #: 16604
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2013
• Est. completion date: December 2020

Study information

• Verified date: April 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated therapy
Shorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Southwest Virginia Regional Cancer Center	Norton	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Timothy Showalter, MD

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute and late GU and GI toxicity		over a period of two years
Other	Health Utilities		1 year after radiation treatment
Other	EPIC Prostate Cancer-Specific QOL instrument	looking at changes in sexual and hormonal domains	over a period of two years
Other	Ancillary financial burden	estimating out-of-pocket costs and lost wages for patients during treatment	over a period of two years
Primary	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
Primary	Quality of life measure	To compare quality of life post-procedure from baseline	over a period of 2 years
Secondary	Biochemical failure rate	A biochemical failure is defined as an increase in prostate serum antigen concentration to nadir plus 2ng/mL or 3 consecutive increases in PSA	over a period of 2 years