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Ultra-Hypofractionated Radiation Therapy in Treating Participants with Early Prostate Cancer

Trial Status: Active

This pilot trial studies the side effects of ultra-hypofractionated radiation therapy, also known as stereotactic body radiation therapy, and how well it works in treating participants with early prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Further shortening the stereotactic body radiation therapy to 2 higher dose treatments, but lower total dose than standard treatment, may work better in treating participants with prostate cancer.

Inclusion Criteria

  • Ability of participant to sign a written informed consent
  • Diagnosed with prostate cancer, T1-T2bN0M0 Gleason score (GS) 6-7; prostate specific antigen (PSA) < 20
  • International Prostate Symptom Score (IPSS) < 18 (and < 10 if on medication for benign prostatic hypertrophy such as tamsulosin) at time of enrollment
  • Prostate volume (by ultrasound [US], computed tomography [CT] or magnetic resonance imaging [MRI] measurement) < 60 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
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
  • 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

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Xinglei Shen
Phone: 913-588-3600
University of Kansas Cancer Center-West
Status: ACTIVE
Contact: Xinglei Shen
Phone: 913-588-3600
Overland Park
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Contact: Xinglei Shen
Phone: 913-588-3663

Missouri

Kansas City
North Kansas City Hospital
Status: ACTIVE
Contact: Xinglei Shen
Phone: 913-588-3600
University of Kansas Cancer Center - North
Status: ACTIVE
Contact: Xinglei Shen
Phone: 913-588-3600
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: ACTIVE
Contact: Xinglei Shen
Phone: 913-588-3600

PRIMARY OBJECTIVE:

I. To demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the Expanded Prostate Cancer Index Composite (EPIC)-26 genitourinary (GU) domain patient reported outcome.

SECONDARY OBJECTIVES:

I. Biochemical control rate.

II. Radiation Therapy Oncology Group (RTOG) toxicity.

III. Financial toxicity of treatment.

EXPLORATORY OBJECTIVES:

I. Oxidative stress as a predictor of toxicity.

II. Blood banking will be obtained for future investigations.

OUTLINE:

Participants undergo stereotactic body radiation therapy (SBRT) over 2 fractions (2-5 days) for 10-20 minutes in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 4 years.

Trial Phase Phase NA

Trial Type Treatment

Lead Organization
University of Kansas Cancer Center

Principal Investigator
Xinglei Shen

  • Primary ID STUDY00141963
  • Secondary IDs NCI-2018-00782
  • Clinicaltrials.gov ID NCT03486821