NCT02423889
Completed
Phase 2
Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy3 sites in 1 country28 target enrollmentApril 2013
ConditionsProstate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Enrollment
- 28
- Locations
- 3
- Primary Endpoint
- Acute toxicity
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per fraction.
Investigators
Stefano Vagge
MD
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Eligibility Criteria
Inclusion Criteria
- •Histology of prostate adenocarcinoma
- •Age≥ 18 years
- •Life expectancy≥ 10 years
- •Clinical negative nodes (N0)
- •No metastasis presence (M0)
- •No previous pelvic radiation therapy
- •Total PSA≤10 ng/ml
- •Gleason score ≤ 6
- •≤ 3 positive biopsy at prostatic mapping
- •Signed informed consent
Exclusion Criteria
- •Positive nodes (N+) or metastatic disease (M+)
- •Inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders
- •Anticoagulant treatment in progress
- •Hip or pelvic presence of medical devices that could prevent a correct image acquisition
- •Symptomatic haemorrhoidal disease
- •Adverse reactions to iodinate or paramagnetic contrast media
- •Previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years
- •Previous pelvic radiotherapy
- •Psychiatric disorder that preclude to obtain informed consent
Outcomes
Primary Outcomes
Acute toxicity
Time Frame: up to 3 months
during treatment and up to 3 month from RT end
Late toxicity
Time Frame: up to 60 months
since 4 month from RT end
Secondary Outcomes
- Disease free survival(up to 5 year)
- Disease specific survival(up to 5 years)
- Overall survival(up to 5 years)
Study Sites (3)
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