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Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers

A

AHS Cancer Control Alberta

Status and phase

Completed
Phase 1

Conditions

Prostate Cancer

Treatments

Procedure: C-Choline PET Scanning
Procedure: Gene Rearrangement
Procedure: 3T MR Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT00676286
GU-24152

Details and patient eligibility

About

This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.

Full description

This study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. This can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. In addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.

Enrollment

26 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically proven adenocarcinoma of the prostate
  • Registration must occur within 16 weeks of last biopsy
  • History and physical exam (including DRE) within 8 weeks prior to registration
  • Patients must have indolent prostate cancer including all of the following: Low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease
  • Patients must have a minimum of six biopsies (sextant) at registration
  • PSA test within 8 weeks registration
  • Creatinine level below 100 umol/L within 8 weeks of registration
  • Patients must have no contraindications to MRI scans
  • No history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
  • Patients must be reliable for follow up

Exclusion criteria

  • Patient does not have histologically-proven adenocarcinoma of the prostate
  • Last biopsy greater than 16 weeks prior to registration
  • History and physical exam (including DRE) greater that 8 weeks prior to registration
  • Patient does not have indolent disease
  • Patient has less than six sextant biopsies at registration
  • PSA test done greater than 8 weeks from registration
  • Creatinine level greater than 100 umol/L within 8 weeks of registration
  • Contraindications to MRI scans
  • History of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy
  • Patients that are not reliable for follow up

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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