An Alternative to A Fixed Schedule In Management Of Prostate Cancer

NCT01056562 | Completed

• 1 other identifier: REB # 09-0526-C
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate; GU; Urological Oncology

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Q6wks x 24 wks

Secondary Outcomes (3)

• Jamar Dynamometer

  Baseline and 18 weeks

• EPIC Quality of Life Questionnaire

  Baseline and 18 weeks

• Six Minute Walk Test

  Baseline and 18 weeks

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men with prostate cancer attending ambulatory clinics at Princess Margaret Hospital

You may qualify if:

• 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)

You may not qualify if:

• Patients on other clinical trials needing continuous androgen deprivation

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ian F Tannock, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: November 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

CA (1)