Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)

A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.

Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).

Study Overview

• Status: Unknown
• Conditions: Prostate Neoplasm
• Intervention / Treatment: Drug: Degarelix

Detailed Description

To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z4E6
      • British Columbia Cancer Agency

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• histologically confirmed adenocarcinoma of the prostate
• currently receiving LHRH agonist
• Anti-androgen oral therapy is permitted but will be discontinued upon enrollment
• PSA > 2 ng/ml
• rising PSA despite LHRH agonist
• patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only
• Prior chemotherapy allowed
• ECOG performance status 0-1

Exclusion Criteria:

• Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.
• Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Degarelix; Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.	Drug: Degarelix; Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.; Other Names: Firmagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
50% fall in PSA	Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist	8 weekly

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Luteinizing hormone (LH)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly
Follicle stimulating hormone (FSH)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly
Testosterone (TT)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly
dehydroepiandrosterone (DHEA)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly
dehydroepiandrosterone-sulfate (DHEA-S)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly
androstenedione (AED)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly
dihydrotestosterone (DHT)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly

Collaborators and Investigators

• Sponsor: British Columbia Cancer Agency
• Collaborators: Ferring Pharmaceuticals
• Investigators: Principal Investigator: Kim N Chi, MD, British Columbia Cancer Agency, Univeristy of British Columbia

Publications and helpful links

General Publications

• Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schroder F, Shore N, Moul JW, Jensen JK, Olesen TK, Persson BE. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol. 2011 Sep;186(3):889-97. doi: 10.1016/j.juro.2011.04.083. Epub 2011 Jul 23.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: castrate resistance; PSA progression; LHRH antagonism
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BCCA_Deg01