Prostate CancerPhase 2PAMISNCT01257425
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
A Phase 2 study testing Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in people with Prostate Cancer, run by Ipsen at 22 sites in Germany.
Trial summary
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer. 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 Pamoate (Pamorelin® LA 11.25 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 22 sitesGermany
- Study dates
- Dec 2010to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
- Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
- Karnofsky performance index > 70
- Expected survival ≥ 9 months
Who cannot join
- Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
- Any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
- Patient at risk of spinal cord compression or ureter obstruction
- Prior hypophysectomy or adrenalectomy
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Germany22 sites
Kreiskrankenhaus, Abteilung Urologie
Bad Bergzaben, 76887
Praxis für Urologie
Bad Ems
Praxis für Urologie
Bamberg, 96047
Praxis für Urologie
Berlin
Praxis für Urologie
Braunschweig
Praxis für Urologie
Cham
Praxis für Urologie
Chemnitz
Praxis für Urologie
Dessau
Praxis für Urologie
Eisleben Lutherstadt
Loretto Krankenhaus, Abteilung Urologie
Freiburg im Breisgau, 79100
Praxis für Urologie
Gelsenkirchen
Praxis für Urologie
Herzberg
Praxis für Urologie
Marburg
Praxis für Urologie
Markkleeberg
Praxis für Urologie
Miltenberg
Praxis für Urologie
Mülheim
Praxis für Urologie
München, 81241
Praxis für Urologie
Neunkirchen
Urologische Klinik
Neunkirchen
Praxis für Urologie
Reutlingen, 72764
Praxis für Urologie
Wesel
Praxis für Urologie
Wuppertal
About this study
Official title: A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
- 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 Pamoate (Pamorelin® LA 11.25 mg)Drug
Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85.
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. | Other | Not described Receives: Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) |
| Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. | Other | Not described Receives: Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
Measured: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
Secondary outcomes (6)
Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)
Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
Measured: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)
Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
Measured: 85, 87, 113, 141 and 169 days post-dose
Maximum Concentration of Serum Testosterone [Cmax] - Raw Data
Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
Measured: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data
Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
Measured: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL
tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.
Measured: 12 weeks
Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL
tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 109 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
- NCT01257425
- Sponsor's protocol ID
- A-94-52014-178
- Other IDs
- 2010-019632-12
- Acronym
- PAMIS
- Status last verified
- Jan 2019
- First submitted
- 8 Dec 2010
- Last updated
- 8 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT01257425
- Acronym / sponsor ID
- PAMIS / A-94-52014-178
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. | Other | Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) |
| Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. | Other | Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
- Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
- Karnofsky performance index > 70
- Expected survival ≥ 9 months
Key exclusion criteria (4 listed)
- Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
- Any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
- Patient at risk of spinal cord compression or ureter obstruction
- Prior hypophysectomy or adrenalectomy
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 Pamoate (Pamorelin® LA 11.25 mg)Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85. Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85. | Drug | Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM., Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. |
Primary outcome
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
Time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
6 secondary outcomes
Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)
Time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)
Time frame: 85, 87, 113, 141 and 169 days post-dose
Maximum Concentration of Serum Testosterone [Cmax] - Raw Data
Time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data
Time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL
Time frame: 12 weeks
Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
22 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 Pamoate (Pamorelin® LA 11.25 mg) in people with Prostate Cancer, run by Ipsen at 22 sites in Germany.
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 4 inclusion and 4 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 26 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d). (time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose). 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 8 Feb 2019.