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A Study of Transrectal Tumour Oxygen Measurements in Patients With Clinically Localized Prostate Cancer


Phase 2
18 Years
80 Years
Open (Enrolling)
Male
Prostatic Neoplasms

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Trial Information

A Study of Transrectal Tumour Oxygen Measurements in Patients With Clinically Localized Prostate Cancer


Inclusion Criteria:



- A histologic diagnosis of adenocarcinoma of the prostate

- A decision to treat using high-dose conformal radiotherapy, with or without
neoadjuvant and concurrent androgen ablation

- Clinical stage T2a or T2b, N0, M0 (UICC 1997 68)

- No hormonal or cytotoxic anti-cancer therapy prior to study entry

- ECOG performance status of 2 or less

- Ability to understand the English language

- Signed informed consent

Exclusion Criteria:

- Patients with prior or active malignancy within 5 years of the diagnosis of prostate
cancer, except non-melanoma skin cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine the relationship between pre-treatment prostate cancer oxygen levels and long-term disease control following treatment with radiotherapy, and the independent prognostic effect of oxygen measurements.

Outcome Time Frame:

after follow-up is completed

Safety Issue:

No

Principal Investigator

Michael Milosevic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 00-0443-C

NCT ID:

NCT00160979

Start Date:

January 2001

Completion Date:

January 2014

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

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