Stereotactic Volumetric Radiotherapy in Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2016
• Main ID: NCT02423889
• Date of registration: 17/04/2015
• Prospective Registration: No
• Primary sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Public title: Stereotactic Volumetric Radiotherapy in Prostate Cancer
• Scientific title: Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study
• Date of first enrolment: April 2013
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02423889
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Italy

Key inclusion & exclusion 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

- T1-2

- = 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Radiation: Radiotherapy

Primary Outcome(s)

Late toxicity [Time Frame: up to 60 months]

Acute toxicity [Time Frame: up to 3 months]

Secondary Outcome(s)

Disease specific survival [Time Frame: up to 5 years]

Disease free survival [Time Frame: up to 5 year]

Overall survival [Time Frame: up to 5 years]

Secondary ID(s)

RITS13.001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors