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

Primary Purpose

Prostate Neoplasm

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Degarelix

About this trial

This is an interventional treatment trial for Prostate Neoplasm focused on measuring castrate resistance, PSA progression, LHRH antagonism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

British Columbia Cancer Agency

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix

Arm Description

Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Luteinizing hormone (LH)

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Follicle stimulating hormone (FSH)

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Testosterone (TT)

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

dehydroepiandrosterone (DHEA)

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

dehydroepiandrosterone-sulfate (DHEA-S)

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

androstenedione (AED)

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

dihydrotestosterone (DHT)

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Full Information

NCT ID

NCT01630967

First Posted

June 25, 2012

Last Updated

June 27, 2012

Sponsor

British Columbia Cancer Agency

Collaborators

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01630967

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

British Columbia Cancer Agency

Collaborators

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Neoplasm

Keywords

castrate resistance, PSA progression, LHRH antagonism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Degarelix

Arm Type

Experimental

Arm Description

Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.

Intervention Type

Drug

Intervention Name(s)

Degarelix

Other Intervention Name(s)

Firmagon

Intervention Description

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

Primary Outcome Measure Information:

Title

50% fall in PSA

Description

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

Time Frame

8 weekly

Secondary Outcome Measure Information:

Title

Luteinizing hormone (LH)

Description

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Time Frame

8 weekly

Title

Follicle stimulating hormone (FSH)

Description

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Time Frame

8 weekly

Title

Testosterone (TT)

Description

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Time Frame

8 weekly

Title

dehydroepiandrosterone (DHEA)

Description

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Time Frame

8 weekly

Title

dehydroepiandrosterone-sulfate (DHEA-S)

Description

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Time Frame

8 weekly

Title

androstenedione (AED)

Description

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Time Frame

8 weekly

Title

dihydrotestosterone (DHT)

Description

Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

Time Frame

8 weekly

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kim N Chi, MD

Phone

+1 604 877 6000

Ext

2746

kim.chi@bccancer.bc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kim N Chi, MD

Organizational Affiliation

British Columbia Cancer Agency, Univeristy of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

British Columbia Cancer Agency

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z4E6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21788033

Citation

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.

Results Reference

result

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

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