Status:

COMPLETED

PROstate Cancer Imaging, Treatment and Toxicity (PROCITT)

Lead Sponsor:

Calvary Mater Newcastle, Australia

Collaborating Sponsors:

Abbott

Conditions:

Prostate Cancer

Eligibility:

MALE

Brief Summary

This is a single centre prospective observational noninterventional study of men with histological confirmed prostate cancer, high risk disease and not positive for metastatic disease planned to recei...

Detailed Description

1. ADT induced Osteoporosis Prostate cancer is a common malignancy in Australian men. In men with localized disease at the time of diagnosis, baseline PSA level, tumour stage and Gleason grade can...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Patient capable of giving informed consent
  • Histological diagnosis of prostate cancer
  • High risk disease defined by any one of:
  • Baseline PSA\>20
  • Gleason grade 8 disease
  • Clinical stage T3-T4
  • Negative conventional staging in the form of a:
  • T99m whole body bone scan
  • CT of the abdomen and pelvis
  • No previous pelvic radiotherapy
  • Exclusion Criteria
  • History of prior malignancy within the last 5 years with the exception of non-melanomatous skin cancers.
  • ECOG performance status \>1
  • Inability to have intraprostatic fiducials inserted.
  • Inability to be given an MRI due to:
  • Implanted magnetic metal eg intraocular metal
  • Pacemaker / Implantable defibrillator
  • Extreme claustrophobia

Exclusion

    Key Trial Info

    Start Date :

    November 28 2012

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 20 2017

    Estimated Enrollment :

    28 Patients enrolled

    Trial Details

    Trial ID

    NCT01418040

    Start Date

    November 28 2012

    End Date

    July 20 2017

    Last Update

    February 5 2018

    Active Locations (1)

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    Calvary Mater Newcastle

    Waratah, New South Wales, Australia, 2305