Ultra-hypofractionated Radiation in Prostate Cancer

NCT03486821 | Completed DMC FDA Device

• 1 other identifier: IIT-2017-PROS-UltraHypoFracRT
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Stage Prostate Cancer

Keywords

Radiation Therapy; ultra-short Radiation; SBRT; prostate; quality of life; financial toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Biochemical Control Rate

  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

  3 year

• RTOG Acute Toxicity Rate

  90 days

• Oxidative stress as a predictor of toxicity

  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

  3 months, 6 months, and 12 month visits only

Study Arms (1)

Hypofrac Radiation Therapy

EXPERIMENTAL

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

Interventions

Hypofractionated Radiation RADIATION

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

Hypofrac Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center/ Cancer Center

Kansas City, Kansas, 66190, United States

Location

MeSH Terms

Conditions

Financial Stress

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Xinglei Shen, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 3, 2018
• Study Start: March 22, 2018
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)