Prostate CancerPhase 2NCT01674270
Degarelix Neo-Adjuvant Radical Prostatectomy Trial
A Phase 2 study testing Degarelix, Casodex and LHRH Agonist in people with Prostate Cancer, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Degarelix, Casodex and LHRH Agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2012to Nov 2015
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men >18 and =< 75 years of age
- Willing and able to provide informed consent, either alone or with the aid of a translator
- Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
- Gleason Score >= 7and/or prostate cancer that is clinical stage T2 disease.
- Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation
- Normal organ and marrow function as defined by the following criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Who cannot join
- Previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole)
- History of receiving radiation to the pelvic area.
- Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization.
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Known hypersensitivity towards any component of the investigational medicinal product or Casodex (bicalutamide) or their excipients.
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- Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms).
- History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome).
- Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
- Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial.
- Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to randomization.
- Mental incapacity or language barrier precluding adequate understanding or co operation.
- Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial.
- Previously participated in any degarelix trial.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University Health Network
Toronto, Ontario, M5G 2M9
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: Phase II Randomized Open Label Study of Neo-Adjuvant Degarelix vs. LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy
To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix, Casodex, LHRH Agonist
- 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
CasodexDrug
LHRH AgonistDrug
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Experimental | Degarelix Alone Receives: Drug: Degarelix |
| Degarelix + Casodex | Experimental | Degarelix and Casodex Receives: Drug: Degarelix; Drug: Casodex |
| LHRH Agonist + Casodex | Active comparator | LHRH Agonist and Casodex Receives: Drug: Casodex; Drug: LHRH Agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratumoral androgen levels
Measured: Week 12
Secondary outcomes (1)
Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674270
- Sponsor's protocol ID
- DEG_PRE-OP_001
- Other IDs
- Degarelix Pre-Op
- Status last verified
- Dec 2015
- First submitted
- 23 Aug 2012
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
PubMed 34350976Sayyid RK, Evans A, Hersey K, Maloni R, Hurtado-Coll A, Kulkarni G, Finelli A, Zlotta AR, Hamilton R, Gleave M, Fleshner NE. A Phase II, Randomized, Open-Label Study of Neoadjuvant Degarelix versus LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy. Clin Cancer Res. 2017 Apr 15;23(8):1974-1980. doi: 10.1158/1078-0432.CCR-16-1790. Epub 2016 Oct 18.
PubMed 27756786
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Open Label Study of Neo-Adjuvant Degarelix vs. LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01674270
- Acronym / sponsor ID
- DEG_PRE-OP_001
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 Aug 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.
To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Degarelix | Experimental | Drug: DegarelixDegarelix Alone |
| Degarelix + Casodex | Experimental | Drug: Degarelix, Drug: CasodexDegarelix and Casodex |
| LHRH Agonist + Casodex | Active comparator | Drug: Casodex, Drug: LHRH AgonistLHRH Agonist and Casodex |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men >18 and =< 75 years of age
- Willing and able to provide informed consent, either alone or with the aid of a translator
- Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
- Gleason Score >= 7and/or prostate cancer that is clinical stage T2 disease.
- Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation
Key exclusion criteria (15 listed)
- Previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole)
- History of receiving radiation to the pelvic area.
- Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization.
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
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 |
|---|---|---|
| Degarelix | Drug | Degarelix, Degarelix + Casodex |
| Casodex | Drug | Degarelix + Casodex, LHRH Agonist + Casodex |
| LHRH Agonist | Drug | LHRH Agonist + Casodex |
Primary outcome
Intratumoral androgen levels
Time frame: Week 12
1 secondary outcome
Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Derived from this study: PubMed 34350976Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
- Derived from this study: PubMed 27756786Sayyid RK, Evans A, Hersey K, Maloni R, Hurtado-Coll A, Kulkarni G, Finelli A, Zlotta AR, Hamilton R, Gleave M, Fleshner NE. A Phase II, Randomized, Open-Label Study of Neoadjuvant Degarelix versus LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy. Clin Cancer Res. 2017 Apr 15;23(8):1974-1980. doi: 10.1158/1078-0432.CCR-16-1790. Epub 2016 Oct 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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, Casodex and LHRH Agonist in people with Prostate Cancer, run by University Health Network, Toronto at 2 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intratumoral androgen levels (time frame: Week 12). 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 NCT01674270, which also lists 2 linked publications.
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 22 Dec 2015.