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Trial record 95 of 1438 for:    prostate cancer AND radiation

Stereotactic Volumetric Radiotherapy in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02423889
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Stefano Vagge, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study
Study Start Date : April 2013
Actual Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. Acute toxicity [ Time Frame: up to 3 months ]
    during treatment and up to 3 month from RT end

  2. Late toxicity [ Time Frame: up to 60 months ]
    since 4 month from RT end


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: up to 5 year ]
    Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease

  2. Disease specific survival [ Time Frame: up to 5 years ]
    Time from RT end to the date of patient death for cancer

  3. Overall survival [ Time Frame: up to 5 years ]
    Time from RT end to the date of patient death for any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423889


Locations
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Italy
IRCCS AOU San Martino-IST
Genoa, GE, Italy, 16132
AO Città della salute e della scienza - Molinette
Turin, TO, Italy
Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia
Brescia, Italy
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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Responsible Party: Stefano Vagge, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT02423889     History of Changes
Other Study ID Numbers: RITS13.001
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Stefano Vagge, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
Hypofractionated radiotherapy
SBRT
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases