Stereotactic Volumetric Radiotherapy in Prostate Cancer

Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy
    • Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia
  • GE
    • Genoa, GE, Italy, 16132
      • IRCCS AOU San Martino-IST
  • TO
    • Turin, TO, Italy
      • AO Città della salute e della scienza - Molinette

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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	Radiation: Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute toxicity	during treatment and up to 3 month from RT end	up to 3 months
Late toxicity	since 4 month from RT end	up to 60 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 17, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: SBRT; Hypofractionated radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: RITS13.001