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A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer (OTT10-06)

Primary Purpose

Prostatic Neoplasms

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Degarelix

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostate, hormone-resistant, degarelix, firmagon, anti-androgens, total androgen blockade, injection

Eligibility Criteria

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

Inclusion Criteria:

Prior trial of total androgen blockade
Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide).
Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan
ECOG ≤ 2
Age ≥ 18 years
Serum testosterone of ≤ 50 mg/dl
PSA ≥ 2.0 ng/ml
White blood cell count ≥ 3000/mm3
Platelets ≥ 100,000/mm3
Serum creatinine ≤ 1.5 x upper limits of normal
Bilirubin ≤ 1.5 x upper limits of normal
Alanine transaminase ≤ 1.25 x upper limits of normal
Estimated life expectancy of at least 12 months
Able and willing to sign informed consent

Exclusion Criteria:

Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur)
Known allergy to GnRH agonists or antagonists
Previous treatment with Degarelix
Major surgery within 4 weeks of registration
Grade ≥ 3 peripheral neuropathy
Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome
Acute deep vein thrombosis or pulmonary embolism
Taking anti-arrhythmia medication
Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years.
Prior orchiectomy for prostate cancer
PSA > 100 ng/mL

Sites / Locations

London Regional Cancer Centre
Ottawa Hospital Cancer Centre
Princess Margeret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix

Arm Description

Degarelix treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.

Outcomes

Primary Outcome Measures

PSA Progression

Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal

Secondary Outcome Measures

Time to Disease progression

Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal

The efficacy of Testosterone, LH and FSH suppression with Degarelix

Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal

The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer

The EPIC-26 Expanded Prostate Cancer Index Composite is used to measure quality of life issues in patients with prostate cancer. The questionnaire will be done months 3 and 6 then every 3 months

Full Information

NCT ID

NCT01545882

First Posted

March 1, 2012

Last Updated

May 5, 2020

Sponsor

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01545882

Brief Title

A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

Acronym

OTT10-06

Official Title

A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

Negative study; Principal Investigator chose to prematurely terminate the study.

Study Start Date

May 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is being offered to patients who have hormone resistant prostate cancer (HRPC). This means that their prostate cancer is no longer responding to standard hormonal therapy. The purpose of this study is to determine whether Degarelix will be able to stop the PSA from rising in patients with hormone resistant prostate cancer.

Detailed Description

This is a phase II study of a GnRH antagonist drug, Degarelix, for use in hormone resistant prostate cancer patients who have had biochemical PSA progression despite the use of total androgen blockade therapy. Patients will receive at least six monthly injections of Degarelix unless the patient shows radiographic or symptomatic disease progression, intolerable toxicity or decides to withdraw from the study. Patients will be evaluated for measures of efficacy, toxicity and disease progression during treatment and afterwards until radiologically confirmed metastatic disease progression or until the patient is removed from the study. Overall objective: The efficacy of Degarelix as a treatment for HRPC will be evaluated

6. Conditions and Keywords

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

Prostatic Neoplasms

Keywords

prostate, hormone-resistant, degarelix, firmagon, anti-androgens, total androgen blockade, injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Degarelix

Arm Type

Experimental

Arm Description

Degarelix treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.

Intervention Type

Drug

Intervention Name(s)

Degarelix

Other Intervention Name(s)

Firmagon

Intervention Description

Treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.

Primary Outcome Measure Information:

Title

PSA Progression

Description

Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal

Time Frame

Monthly for 6 months then every 3 months

Secondary Outcome Measure Information:

Title

Time to Disease progression

Description

Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal

Time Frame

Monthly for 6 months then every 3 months

Title

The efficacy of Testosterone, LH and FSH suppression with Degarelix

Description

Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal

Time Frame

Monthly for 6 months then every 3 months

Title

The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer

Description

The EPIC-26 Expanded Prostate Cancer Index Composite is used to measure quality of life issues in patients with prostate cancer. The questionnaire will be done months 3 and 6 then every 3 months

Time Frame

Month 3 and 6 then every 3 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prior trial of total androgen blockade Confirmed biochemical PSA progression on agonist therapy, defined as ≥ 50% increase in PSA between 2 measurements, taken at least 1 week apart. In patients that are currently on total androgen blockade (LHRH agonist plus non-steroidal anti-androgen) there must be a trial withdrawal of androgen receptor antagonists to ensure that there is no PSA response (6 weeks for bicalutamide and 4 weeks for flutamide or nilutamide). Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan ECOG ≤ 2 Age ≥ 18 years Serum testosterone of ≤ 50 mg/dl PSA ≥ 2.0 ng/ml White blood cell count ≥ 3000/mm3 Platelets ≥ 100,000/mm3 Serum creatinine ≤ 1.5 x upper limits of normal Bilirubin ≤ 1.5 x upper limits of normal Alanine transaminase ≤ 1.25 x upper limits of normal Estimated life expectancy of at least 12 months Able and willing to sign informed consent Exclusion Criteria: Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, PC-SPES, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or Androcur) Known allergy to GnRH agonists or antagonists Previous treatment with Degarelix Major surgery within 4 weeks of registration Grade ≥ 3 peripheral neuropathy Severe, active co-morbidity such as unstable angina, congestive heart failure or myocardial infarction within the last 6 months or congenital long QT syndrome Acute deep vein thrombosis or pulmonary embolism Taking anti-arrhythmia medication Second malignancy other than non-melanoma skin cancer unless disease free ≥ 5 years. Prior orchiectomy for prostate cancer PSA > 100 ng/mL

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shawn Malone, Dr.

Organizational Affiliation

The Ottawa Hospital Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Regional Cancer Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Ottawa Hospital Cancer Centre

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H8L6

Country

Canada

Facility Name

Princess Margeret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

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