AzTrials
AzTrials

Prostate CancerPhase 2NCT02423889

Stereotactic Volumetric Radiotherapy in Prostate Cancer

A Phase 2 study testing Radiotherapy in people with Prostate Cancer, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer
What is being tested?
Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesItaly
Study dates
Apr 2013to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histology of prostate adenocarcinoma
  • Age≥ 18 years
  • Life expectancy≥ 10 years
  • Clinical negative nodes (N0)
  • No metastasis presence (M0)
  • No previous pelvic radiation therapy
Show all 11Show fewer
  • Total PSA≤10 ng/ml
  • Gleason score ≤ 6
  • T1-2
  • ≤ 3 positive biopsy at prostatic mapping
  • Signed informed consent

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia

    Brescia

  • IRCCS AOU San Martino-IST

    Genoa, GE, 16132

  • AO Città della salute e della scienza - Molinette

    Turin, TO

Other trials in Italy

About this study

Official title: 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.

Conditions
Prostate Cancer
Being tested
Radiotherapy
Keywords
Hypofractionated radiotherapy, SBRT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

Study groups in NCT02423889
Study groupRoleWhat they receive
1ExperimentalStereotactic 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
Receives: Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute toxicity

    during treatment and up to 3 month from RT end

    Measured: up to 3 months

  2. Late toxicity

    since 4 month from RT end

    Measured: up to 60 months

Secondary outcomes (3)

  1. Disease free survival

    Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease

    Measured: up to 5 year

  2. Disease specific survival

    Time from RT end to the date of patient death for cancer

    Measured: up to 5 years

  3. Overall survival

    Time from RT end to the date of patient death for any cause

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02423889
Sponsor's protocol ID
RITS13.001
Status last verified
May 2016
First submitted
17 Apr 2015
Last updated
11 May 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy in people with Prostate Cancer, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02423889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in