Stereotactic Volumetric Radiotherapy in Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT02423889
• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Primary Completion: 2015-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Radiotherapy	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

Primary Outcome Measures

Name	Time	Method
Acute toxicity	up to 3 months	during treatment and up to 3 month from RT end
Late toxicity	up to 60 months	since 4 month from RT end

Secondary Outcome Measures

Name	Time	Method
Disease specific survival	up to 5 years	Time from RT end to the date of patient death for cancer
Overall survival	up to 5 years	Time from RT end to the date of patient death for any cause
Disease free survival	up to 5 year	Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease

Trial Locations

Locations (3)

IRCCS AOU San Martino-IST; 🇮🇹 Genoa, GE, Italy

AO Città della salute e della scienza - Molinette; 🇮🇹 Turin, TO, Italy

Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia; 🇮🇹 Brescia, Italy