Clinical trial · Interventional
A Phase I-II Study on Stereotactic Body Radiotherapy in 3 Fractions for Low/Int Risk Prostate Cancer
A Phase I-II Study on the Tolerance and Efficacy of SBRT in 3 Fractions for Low/Int Risk Prostate Cancer
NCT02623647CI-TRIAL-00050561eHYPOunknownN/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 present is a phase I-II study testing the safety and the efficacy of extremely hypofractionated radiotherapy for early stage prostate cancer. The study is designed to assess GU toxicity while controlling tumor control, in terms of survival free from biochemical failure. 40 Gy in fxs will be delivered to patients with low and favourable intermediate risk prostate tumors.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiotherapy SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- A single-arm, nonrandomized
- description
- stereotactic body radiotherapy SBRT, 40 Gy for 3 fractions
- interventionNames
- Radiation: stereotactic body radiotherapy SBRT
Primary outcomes (1)
- measure
- grade 2+ GU toxicity according to CTCv4.0
- timeFrame
- 1 yr
- description
- Hematuria (A disorder characterized by laboratory test results that indicate blood in the urine) Urinary incontinence ( A disorder characterized by inability to control the flow of urine from the bladder.)
Secondary outcomes (1)
- measure
- biochemical failure according to Phoenix definition (nadir + 2 ng/ml)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age (\>18 yrs/old) * low risk prostate cancer defined as primary tumor stage according to AJCC 2010: T1-2a and Gleason Score-GLS: 3+3 and serum Prostate Specific Antigen-PSA: PSA\<10 ng/ml); or among intermediate risk prostate cancer defined as clinical stage T2b-c or GLS 7 or PSA of 10-20 ng/ml, only patients with favourable characteristics: a single factor for intermediate risk AND GLS 3 + 4 AND \<50% of biopsy cores containing cancer (12 cores as a minimum). Exclusion Criteria: * prior radiotherapy * concomitant androgen deprivation * pt failure to consent
References
Publications (0)
Data not yet available
No reference posted for this study.