Status:
ACTIVE_NOT_RECRUITING
Ultra-hypofractionated Radiation in Prostate Cancer
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Early Stage Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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.
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 fe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03486821
Start Date
March 22 2018
End Date
March 1 2026
Last Update
September 19 2024
Active Locations (1)
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1
University of Kansas Medical Center/ Cancer Center
Kansas City, Kansas, United States, 66190