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Completed

NCT Number: NCT02423889

Stereotactic Volumetric Radiotherapy in Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IRCCS AOU San Martino-IST, Genoa, GE, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
First posted
Apr 22, 2015
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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