Clinical trial · Interventional
Ultra-hypofractionated Radiation in Prostate Cancer
Pilot Trial of Ultra-hypofractionated Radiation in Early Prostate Cancer
NCT03486821CI-TRIAL-00110467completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofrac Radiation Therapy
- description
- 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.
- interventionNames
- Radiation: Hypofractionated Radiation
Primary outcomes (1)
- measure
- Toxicity Rates
- timeFrame
- up to 5 year post radiation
- description
- Patient reported urinary function, as defined by the EPIC-26 GU domain patient reported outcome for prostate cancer patients
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.