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Testosterone-Guided Schedule of Androgen Deprivation Therapy (ADT) as an Alternative to A Fixed Schedule In Management Of Prostate Cancer


Phase 4
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Testosterone-Guided Schedule of Androgen Deprivation Therapy (ADT) as an Alternative to A Fixed Schedule In Management Of Prostate Cancer


Inclusion Criteria:



- Pathological evidence of adenocarcinoma of the prostate

- Have been Receiving an LHRH agonist (in the form of a 3-monthly depot) for at least
12 months

- Serum testosterone level below 1.5 nMol/L (≈43 mg/dl)

Exclusion Criteria:

- Patients on other clinical trials needing continuous androgen deprivation

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

We will monitor serum testosterone initially q 6 weeks increasing to every three months and delay initiating the next dose of ADT until serum testosterone level rises above 1.5nMol/l.

Outcome Time Frame:

Baseline, Q6wks x 24 wks

Safety Issue:

No

Principal Investigator

Ian F Tannock, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

UHN Research Ethics Board Canada:

Study ID:

REB # 09-0526-C

NCT ID:

NCT01056562

Start Date:

November 2009

Completion Date:

November 2013

Related Keywords:

  • Prostate Cancer
  • Prostate
  • GU
  • Urological Oncology
  • Prostatic Neoplasms

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