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Spots Global Cancer Trial Database for Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists

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Trial Identification

Brief Title: Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists

Official Title: Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)

Study ID: NCT01366053

Conditions

Prostate Cancer

Interventions

Study Description

Brief Summary: This Phase IV observational trial is intended to identify patients who are failing GnRH agonist therapy as evidenced by a rising PSA and who have yet to initiate secondary manoeuvres involving antiandrogens. This group may include both non-metastatic as well as metastatic patients. The trial will determine if these patients will benefit from switching to Degarelix. It will assess the effect of Degarelix's direct mode of action on androgen levels and whether continuous use of Degarelix improves disease progression. As per the CUA Guidelines for the Management of CRPC, because the androgen receptor remains active in most patients who have developed castration resistant disease, it is recommended that ADT should be continued (LEVEL 3, GRADE C). Therefore, it is logical to continue patients on Degarelix throughout the castrate resistant period. This will allow for the gathering of data that is currently unknown within this setting, such as the effect of combined treatment with antiandrogens as well as chemotherapy and other castrate resistant treatments.

Detailed Description: This trial will include hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists but prior to use of secondary hormonal treatments such as antiandrogens. The purpose of this trial is to determine the effect of Degarelix's direct mode of action on androgen levels and whether continuous use of Degarelix improves disease progression. This is an open-label, multi-centre, Phase IV observational trial with s.c. injections of Degarelix one-month depot in patients with advanced prostate cancer. The visit frequency is once a month (28-day intervals), with eCRF data entry at every 4 months. All patients will be treated with a one-month starting dose followed by 23 monthly maintenance doses for a duration of 672 days. The primary endpoints will be evaluated after 24 treatment months. In total, 25 visits are scheduled for all patients.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Exdeo Clinical Research Inc., Abbotsford, British Columbia, Canada

Southern Interior Medical Research Inc., Kelowna, British Columbia, Canada

Andreou Research, Surrey, British Columbia, Canada

Dr. Steinhoff Clinical Research, Victoria, British Columbia, Canada

The Male/Female Health and Research Centre, Barrie, Ontario, Canada

Jonathan Giddens Medicine Professional Corporation, Brampton, Ontario, Canada

Brantford Urology Research, Brantford, Ontario, Canada

G. Kenneth Jansz Medicine Professional Corporation, Burlington, Ontario, Canada

Guelph Urology Associates, Guelph, Ontario, Canada

Mor Urology Inc., Newmarket, Ontario, Canada

Toronto Urology Clinical Study Group, North York, Ontario, Canada

The Fe/Male Health Centres, Oakville, Ontario, Canada

2150935 Ontario Inc., Owen Sound, Ontario, Canada

643094 Ontario Inc., Scarborough, Ontario, Canada

Stanley Flax Medical Professional Corporation, Toronto, Ontario, Canada

Urology South Shore Research Inc., Greenfield Park, Quebec, Canada

Urolaval, Laval, Quebec, Canada

Contact Details

Name: Richard Casey, M.D.

Affiliation: CMX Research

Role: PRINCIPAL_INVESTIGATOR

Name: Alvaro Morales, M.D.

Affiliation: Queens University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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