Prostate CancerPhase 2NCT00444639
Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)
A Phase 2 study testing Triptorelin (Decapeptyl®) in people with Prostate Cancer, run by Ipsen at 15 sites in Netherlands.
Trial summary
The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Triptorelin (Decapeptyl®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 15 sitesNetherlands
- Study dates
- Feb 2007to Jun 2008
- 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
- Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy
- Life expectancy of more than 9 months
- Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months
Who cannot join
- Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure
- Has previously received a GnRH analogue, estrogens or a steroidal anti -androgen within the last year preceding the study
- Concomitant anti-coagulation treatment
- Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study
- Patient with known spinal medullar compression
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Netherlands15 sites
Vrije Universiteit Medisch Centrum
Amsterdam, 1081 HV
AMC Amsterdam
Amsterdam, 1105 AZ
Alysis Zorggroep Loc. Rijnstate
Arnhem, 6815 AD
Maasziekenhuis Pantein
Boxmeer, 5831 HA
Deventer Ziekenhuis
Deventer, 7415 EH Deventer
Ziekenhuis Gelderse Vallei
Ede, 61717
St. Anna Ziekenhuis Geldrop
Geldrop, 5664 EH
Groen Hart Ziekenhuis
Gouda, 2803 HH
Ziekenhuis Hilversum
Hilversum, 1213 XZ
Westfries Gasthuis Hoorn
Hoorn, 1642 NP
Diaconessenhuis Leiden
Leiden, 2334 CK
Erasmus MC Rotterdam
Rotterdam, 3015 GD
Antonius Ziekenhuis
Sneek, 8601 ZK
UMC Utrecht
Utrecht, 3584 CX
Albert Schweitzer Ziekenhuis
Zwijndrecht, 3331 LZ
About this study
Official title: Phase II Multi-Centric, Randomised, Open-label, Parallel-Group Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer
The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.
- Conditions
- Prostate Cancer
- Being tested
- Triptorelin (Decapeptyl®)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin (Decapeptyl®)Drug
Two injections of 11.25mg given every 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | triptorelin 11.25mg given 12 weekly by subcutaneous formulation Receives: Drug: Triptorelin (Decapeptyl®) |
| 2 | Active comparator | triptorelin 11.25mg given 12 weekly by intramuscular injection Receives: Drug: Triptorelin (Decapeptyl®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
Measured: Week 24
Secondary outcomes (3)
Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS).
Measured: Measured at baseline and 12 weeks
Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS).
Measured: Measured at baseline and 12 weeks
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
Measured: Measured at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionJun 2008
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444639
- Sponsor's protocol ID
- I-48-52014-142
- Other IDs
- 2005-005058-31, 2005
- Status last verified
- Nov 2019
- First submitted
- 7 Mar 2007
- Last updated
- 22 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multi-Centric, Randomised, Open-label, Parallel-Group Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00444639
- Acronym / sponsor ID
- I-48-52014-142
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 Mar 2007 (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.
The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Triptorelin (Decapeptyl®)triptorelin 11.25mg given 12 weekly by subcutaneous formulation |
| 2 | Active comparator | Drug: Triptorelin (Decapeptyl®)triptorelin 11.25mg given 12 weekly by intramuscular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy
- Life expectancy of more than 9 months
- Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months
Key exclusion criteria (5 listed)
- Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure
- Has previously received a GnRH analogue, estrogens or a steroidal anti -androgen within the last year preceding the study
- Concomitant anti-coagulation treatment
- Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study
- Patient with known spinal medullar compression
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 |
|---|---|---|
| Triptorelin (Decapeptyl®)Two injections of 11.25mg given every 12 weeks | Drug | 1, 2 |
Primary outcome
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
Time frame: Week 24
3 secondary outcomes
Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS).
Time frame: Measured at baseline and 12 weeks
Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS).
Time frame: Measured at baseline and 12 weeks
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
Time frame: Measured at week 12
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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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.
Ipsen Medical Director study director
Ipsen
15 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 Triptorelin (Decapeptyl®) in people with Prostate Cancer, run by Ipsen at 15 sites in Netherlands.
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 3 inclusion and 5 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 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands. 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: Low recruitment). 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?
Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l). (time frame: Week 24). 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 22 Nov 2019.