Ultra-hypofractionated Radiation in Prostate Cancer

Pilot Trial of Ultra-hypofractionated Radiation in Early Prostate Cancer

The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.

Study Overview

• Status: Active, not recruiting
• Conditions: Early Stage Prostate Cancer
• Intervention / Treatment: Radiation: Hypofractionated Radiation

Detailed Description

This is a pilot clinical trial looking at 2 fraction SBRT radiation therapy as an alternative to standard of care. Data does not yet exist for the safety and efficacy of this regimen.

However, the feasibility of ultra-short radiation therapy treatments has already been demonstrated in an analogous treatment using high-dose rate (HDR) brachytherapy. HDR brachytherapy has been adopted at high volume cancers centers as a standard treatment for prostate cancer. Typical doses have been 26 - 27 Gy over 2 fractions (13 or 13.5 Gy per fraction). Overall, toxicity and efficacy of HDR brachytherapy have compared favorably to other treatment modalities.

Dosimetric planning models between SBRT and HDR brachytherapy suggest minor differences. HDR brachytherapy was able to achieve higher intraprostatic maximum doses and lower rectal doses, but target volume coverage and urethral dose was not significantly different. These data suggest that reducing SBRT treatments from 5 fractions to 2 fractions may be feasible, efficacious and tolerable.

Eligible patients include all patients who are otherwise eligible for standard 5 fraction SBRT prostate. Study population will be low and intermediate patients with good urinary function (as defined by small prostate volume and low IPSS score). SBRT treatment will be delivered to the prostate to 12.5 Gy x 2 fractions.

Hormonal therapy is permitted on this study. Permitted agents include: leuprolide (Lupron/Eligard), biclutamide (Casodex), and degarelix (Firmagon).

Rectal sparing with hydrogel spacer (SpaceOAR) will be encouraged.

All patients will be enrolled with interim safety analyses after every occurrence of a grade 3 acute or late toxicity. Interval safety analysis will also be performed for recurrence and decrease in EPIC GU domain quality of life. Biospecimen and financial toxicity data will also be collected.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tina K Livingood; Phone Number: 913-574-0015; Email: clivingood@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66190
      • University of Kansas Medical Center/ Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Ability of participant to sign a written informed consent.
• Diagnosed with prostate cancer, T1-T2bN0M0 GS6-7, PSA < 20
• IPSS score < 15 (and < 10 if on medication for benign prostatic hypertrophy such as tamsulosin) at time of enrollment (Appendix 21.4)
• Prostate volume (by US, CT or MRI measurement) < 50 cc at time of enrollment
• Androgen deprivation therapy based on clinician judgment is permitted on study
• Life expectancy > 10 years based on clinician's judgment
• No other active malignancy
• Age ≥ 18 years
• Performance Status Eastern Cooperative Oncology Group (ECOG) 0-1 (Appendix 21.5).
• Other study-specific criteria:
• Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment.

NOTE: Acceptable forms of birth control are listed below:

• One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS
• Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T).

Exclusion Criteria:

• Current or anticipated use of other investigational agents while participating in this study.
• Psychiatric illness/social situations that would limit compliance with study requirements
• Prior pelvic radiation therapy
• Prior prostatectomy
• Inflammatory bowel disease or connective tissue disease requiring medical management

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hypofrac Radiation Therapy; All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy. Radiation treatment will start approximately 1-2 weeks after the simulation scan. Prior to each treatment, you will be asked to have a full bladder and empty rectum. You will be asked to take a liquid diet starting the afternoon prior to each treatment, and a laxative (such as Miralax) in the evening prior to each treatment. You will also be asked to take a Fleet's enema about 1 hours prior to the treatment time to ensure that the rectum is empty. To ensure full bladder, you will be asked to drink about 32 oz of water after the enema. This is the same procedure as above for the prep before the simulation scan. Each treatment should take about 10-20 minutes.

Radiation: Hypofractionated Radiation; All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity Rates	Patient reported urinary function, as defined by the EPIC-26 GU domain patient reported outcome for prostate cancer patients	up to 5 year post radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical Control Rate	Biochemical freedom from progression as defined by ASTRO Phoenix criteria at 3 years	1 month post-Radiation Therapy (RT), every 3 months- post RT for the first year and then every 6 months post RT for the next 4 years
Radiation Therapy Oncology Group (RTOG) Late Toxicity Rate	Rate of Grade 3+ gastrointestinal (GI) or genitourinary (GU) late toxicity at 3 years as defined by RTOG late toxicity scored on a 1 to 4 scale with a higher value representing a worse outcome.	3 year
RTOG Acute Toxicity Rate	Rate of Grade 2+ GI or GU acute toxicity within 90 days of treatment as defined by RTOG acute toxicity scored on a 1 to 4 scale with a higher value representing a worse outcome.	90 days
Oxidative stress as a predictor of toxicity	exploring the oxidative stress markers of the patient to use as a predictor of acute and late toxicty	1 month post-RT, every 3 months- post RT for the first year and then every 6 months post RT for the next 4 years
Financial Toxicity Measurement	Determined by evaluation of patient completion of questionnaire	3 months, 6 months, and 12 month visits only

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; SBRT; Radiation Therapy; prostate; ultra-short Radiation; financial toxicity
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IIT-2017-PROS-UltraHypoFracRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No