Stereotactic Volumetric Radiotherapy in Prostate Cancer

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02423889

RITS13.001

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

1

Experimental group

Description:

Stereotactic radiotherapy with a total dose of 36.25 Gy in 5 fractions (7.25 Gy per fraction, 2 fractions per week) in low risk prostate cancer patients is delivered to evaluate acute and subacute toxicty

Treatment:

Radiation: Radiotherapy