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An Alternative to A Fixed Schedule In Management Of Prostate Cancer (TADS)

This study is currently recruiting participants.
Verified June 2012 by University Health Network, Toronto
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01056562
First received: January 22, 2010
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

The male sex-hormone called testosterone is known to play a key role in the growth of prostate cancer. The usual treatment for the disease involves suppression of hormones (testosterone) by anti-hormonal treatment for an unknown period of time until the cancer progresses. This anti-hormonal treatment usually consists of injections every three months with an LHRH(Leutinizing Hormone-Releasing Hormone) agonist and a short course of anti-androgen pills, which together help to lower the production of testosterone. Long-term hormonal treatment has potentially serious side effects and is expensive.

In this study, hormonal treatments will be with held from those patients eligible and willing to participate. The aim of this study is to see if we can decrease the amount of hormone injections that patients require. This might lead to a decreased side effects(such as decrease in bone health, cardiovascular problems and metabolic syndrome which occurs when several health conditions happen at the same time and can lead to an increased risk of heart disease, stroke and diabetes) as well as to decrease the cost of hormonal therapy to treat prostate cancer.


Condition Phase
Prostate Cancer
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Testosterone-Guided Schedule of Androgen Deprivation Therapy (ADT) as an Alternative to A Fixed Schedule In Management Of Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline, Q6wks x 24 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Jamar Dynamometer [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
  • EPIC Quality of Life Questionnaire [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
  • Six Minute Walk Test [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Men with prostate cancer attending ambulatory clinics at Princess Margaret Hospital

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056562

Contacts
Contact: Anna J Dodd 416-946-4501 ext 3176 anna.dodd@uhn.on.ca
Contact: Saroj Niraula, MD 416-946-4501 ext 2245 saroj.niraula@uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Anna Dodd     416-946-4501 ext 3176     anna.dodd@uhn.on.ca    
Sub-Investigator: Saroj Niraula, MD            
Sub-Investigator: Anthony Joshua, MD            
Sub-Investigator: Shabbir Alibhai, MD            
Sub-Investigator: Peter Cheung, PhD            
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Ian F Tannock, MD, PhD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Ian F. Tannock, Princess Margaret Hospital, University Health Network
ClinicalTrials.gov Identifier: NCT01056562     History of Changes
Other Study ID Numbers: REB # 09-0526-C
Study First Received: January 22, 2010
Last Updated: June 26, 2012
Health Authority: UHN Research Ethics Board Canada:

Keywords provided by University Health Network, Toronto:
Prostate
GU
Urological Oncology

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013