Stereotactic Volumetric Radiotherapy in Prostate Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02423889

Enrollment

Registered

2015-04-22

Start date

2013-04-30

Completion date

Unknown

Last updated

2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Hypofractionated radiotherapy, SBRT

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.

Interventions

RADIATIONRadiotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Disease free survival	up to 5 year	Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026