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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University Health Network, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01007825
First received: November 3, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The preferred cost-benefit strategy for long-term use of LHRH agonists will be based on measurement of serum testosterone rather than regular dosing


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
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:


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

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Men with castration resistant prostate cancer who have been on contineous androgen deprivation therapy for at least a year

Criteria

Inclusion Criteria:

  • Pathological evidence of adenocarcinoma of the prostate
  • Receiving an LHRH agonist (in the form of a 3-4 monthly depot) for at least one year.(They may be receiving additional hormonal medications).
  • Serum testosterone level below 1.75 nMol/L

Exclusion Criteria:

  • Patients on other clinical trials needing continuous androgen deprivation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ian Tannock, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT01007825     History of Changes
Other Study ID Numbers: TADS
Study First Received: November 3, 2009
Last Updated: November 3, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Androgen Deprivation
ADT
Testosterone
LHRH
Prostate
To explore the following
Saving of cost achieved by dosing the LHRH agonist on the basis of measurement of testosterone as compared to routine 3-monthly injection
Relation between serum testosterone and time after stopping an LHRH agonist
Clinical factors that influence recovery of testosterone post-LHRH
Change in physical function after holding LHRH treatment

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 30, 2014