Stereotactic Volumetric Radiotherapy in Prostate Cancer
Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study
1 other identifier
interventional
28
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 17, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedMay 11, 2016
May 1, 2016
2.4 years
April 17, 2015
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Disease free survival
up to 5 year
Disease specific survival
up to 5 years
Overall survival
up to 5 years
Study Arms (1)
1
EXPERIMENTALStereotactic 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
IRCCS AOU San Martino-IST
Genoa, GE, 16132, Italy
AO Città della salute e della scienza - Molinette
Turin, TO, Italy
Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia
Brescia, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 17, 2015
First Posted
April 22, 2015
Study Start
April 1, 2013
Primary Completion
September 1, 2015
Last Updated
May 11, 2016
Record last verified: 2016-05