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Ultra-hypofractionated Radiation in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03486821
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : September 3, 2020
Information provided by (Responsible Party):
Xinglei Shen, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Early Stage Prostate Cancer Radiation: Hypofractionated Radiation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Ultra-hypofractionated Radiation in Early Prostate Cancer
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.

Primary Outcome Measures :
  1. Toxicity Rates [ Time Frame: up to 5 year post radiation ]
    Patient reported urinary function, as defined by the EPIC-26 GU domain patient reported outcome for prostate cancer patients

Secondary Outcome Measures :
  1. Biochemical Control Rate [ Time Frame: 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 ]
    Biochemical freedom from progression as defined by ASTRO Phoenix criteria at 3 years

  2. Radiation Therapy Oncology Group (RTOG) Late Toxicity Rate [ Time Frame: 3 year ]
    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. RTOG Acute Toxicity Rate [ Time Frame: 90 days ]
    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.

  4. Oxidative stress as a predictor of toxicity [ Time Frame: 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 ]
    exploring the oxidative stress markers of the patient to use as a predictor of acute and late toxicty

  5. Financial Toxicity Measurement [ Time Frame: 3 months, 6 months, and 12 month visits only ]
    Determined by evaluation of patient completion of questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03486821

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Contact: Tina K Livingood 913-574-0015
Contact: Michelle Faucheux, RN 913-588-9927

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United States, Kansas
University of Kansas Medical Center/ Cancer Center Recruiting
Kansas City, Kansas, United States, 66190
Contact: Tina Livingood    913-574-0015   
Contact: Amanda Schroeder    913-588-3600   
Sponsors and Collaborators
University of Kansas Medical Center
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Principal Investigator: Xinglei Shen, MD University of Kansas Medical Center
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Responsible Party: Xinglei Shen, Medical Doctor, University of Kansas Medical Center Identifier: NCT03486821    
Other Study ID Numbers: IIT-2017-PROS-UltraHypoFracRT
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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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
Keywords provided by Xinglei Shen, University of Kansas Medical Center:
Radiation Therapy
ultra-short Radiation
quality of life
financial toxicity
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases