Prostatic NeoplasmsPhase 2OTT10-06NCT01545882
A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer
A Phase 2 study testing Degarelix in people with Prostatic Neoplasms, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Degarelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesCanada
- Study dates
- May 2011to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
London Regional Cancer Centre
London, Ontario, N6A 4L6
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H8L6
Princess Margeret Hospital
Toronto, Ontario, M5G 2M9
About this study
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.
Read the 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
- Conditions
- Prostatic Neoplasms
- Being tested
- Degarelix
- Keywords
- prostate, hormone-resistant, degarelix, firmagon, anti-androgens, total androgen blockade, injection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Also called Firmagon
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.
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Experimental | 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. Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Monthly for 6 months then every 3 months
Secondary outcomes (3)
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
Measured: Monthly for 6 months then every 3 months
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
Measured: Monthly for 6 months then every 3 months
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
Measured: Month 3 and 6 then every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionJul 2013
Why it stopped: Negative study; Principal Investigator chose to prematurely terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawn Malone, Dr., Principal investigator, The Ottawa Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545882
- Sponsor's protocol ID
- 10-059
- Other IDs
- OTT10-06
- Acronym
- OTT10-06
- Status last verified
- May 2020
- First submitted
- 1 Mar 2012
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT01545882
- Acronym / sponsor ID
- OTT10-06 / 10-059
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate, hormone-resistant, degarelix, firmagon, anti-androgens, total androgen blockade, injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Negative study; Principal Investigator chose to prematurely terminate the study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degarelix | Experimental | Drug: DegarelixDegarelix 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DegarelixAlso: FirmagonTreatment 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. | Drug | Degarelix |
Primary outcome
PSA Progression
Time frame: Monthly for 6 months then every 3 months
Blood work will be done once a month during the 6 months of treatment then every 3 months until disease progression or participant withdrawal
3 secondary outcomes
Time to Disease progression
Time frame: Monthly for 6 months then every 3 months
The efficacy of Testosterone, LH and FSH suppression with Degarelix
Time frame: Monthly for 6 months then every 3 months
The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer
Time frame: Month 3 and 6 then every 3 months
Results and safety
The study was stopped early (reason given: Negative study; Principal Investigator chose to prematurely terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Malone, Dr. principal investigator
The Ottawa Hospital Cancer Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Degarelix in people with Prostatic Neoplasms, run by Ottawa Hospital Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Negative study; Principal Investigator chose to prematurely terminate the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Progression (time frame: Monthly for 6 months then every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.