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

Prostate Neoplasm Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01630967
• Other study ID #: BCCA_Deg01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 25, 2012
• Last updated: June 27, 2012
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: British Columbia Cancer Agency
• Contact: Kim N Chi, MD
• Phone: +1 604 877 6000
• Email: kim.chi[@]bccancer.bc.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schröder 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 anta — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Luteinizing hormone (LH)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly	No
Secondary	Follicle stimulating hormone (FSH)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly	No
Secondary	Testosterone (TT)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly	No
Secondary	dehydroepiandrosterone (DHEA)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly	No
Secondary	dehydroepiandrosterone-sulfate (DHEA-S)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly	No
Secondary	androstenedione (AED)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly	No
Secondary	dihydrotestosterone (DHT)	Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).	8 weekly	No