Prostate NeoplasmPhase 2NCT01630967
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 2 study testing Degarelix in people with Prostate Neoplasm, run by British Columbia Cancer Agency at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasm
- 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
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Dec 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z4E6
About this study
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.
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).
Read the 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.
- Conditions
- Prostate Neoplasm
- Being tested
- Degarelix
- Keywords
- castrate resistance, PSA progression, LHRH antagonism
- 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
Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Experimental | Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression. Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weekly
Secondary outcomes (7)
Luteinizing hormone (LH)
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Measured: 8 weekly
Follicle stimulating hormone (FSH)
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Measured: 8 weekly
Testosterone (TT)
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Measured: 8 weekly
dehydroepiandrosterone (DHEA)
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Measured: 8 weekly
dehydroepiandrosterone-sulfate (DHEA-S)
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Measured: 8 weekly
androstenedione (AED)
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Measured: 8 weekly
dihydrotestosterone (DHT)
Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).
Measured: 8 weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startAug 2012 (estimated)
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Site did not proceed with this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Principal investigator, Kim Chi, British Columbia Cancer Agency
- Investigators
- Kim N Chi, MD, Principal investigator, British Columbia Cancer Agency, Univeristy of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630967
- Sponsor's protocol ID
- BCCA_Deg01
- Status last verified
- Jun 2012
- First submitted
- 25 Jun 2012
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21788033
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01630967
- Acronym / sponsor ID
- BCCA_Deg01
- Conditions
- Prostate Neoplasm
- Keywords
- castrate resistance, PSA progression, LHRH antagonism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site did not proceed with this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Aug 2012 (estimated)
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 Jun 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.
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.
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 240mg subcutaneously loading dose, then 80mg sc every month until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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: FirmagonStandard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose. | Drug | Degarelix |
Primary outcome
50% fall in PSA
Time frame: 8 weekly
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
7 secondary outcomes
Luteinizing hormone (LH)
Time frame: 8 weekly
Follicle stimulating hormone (FSH)
Time frame: 8 weekly
Testosterone (TT)
Time frame: 8 weekly
dehydroepiandrosterone (DHEA)
Time frame: 8 weekly
dehydroepiandrosterone-sulfate (DHEA-S)
Time frame: 8 weekly
androstenedione (AED)
Time frame: 8 weekly
dihydrotestosterone (DHT)
Time frame: 8 weekly
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Results publication: PubMed 21788033Crawford 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.
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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.
Kim N Chi, MD principal investigator
British Columbia Cancer Agency, Univeristy of British Columbia
1 site 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 Prostate Neoplasm, run by British Columbia Cancer Agency at 1 site 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 8 inclusion and 2 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: withdrawn, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
50% fall in PSA (time frame: 8 weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630967, which also lists 1 linked publication.
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 1 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.