Stereotactic Volumetric Radiotherapy in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423889
• Other study ID #: RITS13.001
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2015
• Last updated: May 10, 2016
• Start date: April 2013

Study information

• Verified date: May 2016
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiotherapy

Locations

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

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity	during treatment and up to 3 month from RT end	up to 3 months	Yes
Primary	Late toxicity	since 4 month from RT end	up to 60 months	Yes
Secondary	Disease free survival	Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease	up to 5 year	Yes
Secondary	Disease specific survival	Time from RT end to the date of patient death for cancer	up to 5 years	Yes
Secondary	Overall survival	Time from RT end to the date of patient death for any cause	up to 5 years	Yes