Prostatic NeoplasmPhase 3NCT00751790
Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
A Phase 3 study testing triptorelin embonate (INN) in people with Prostatic Neoplasm, run by Debiopharm International SA at 1 site in South Africa.
Trial summary
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment >90% of the patients would achieve and maintain castrate levels of serum testosterone. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- triptorelin embonate (INN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jul 2006to Aug 2007
- Phase
- Phase 3
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically proven prostate cancer.
- The prostate cancer should be staged T3-4NxMx or TxN1-3Mx or TxNxM1 according to the TNM classification or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy.
- Serum testosterone levels >5 nmol/L.
- Karnofsky performance index >40.
- Expected survival > 18 months.
- Absence of another malignancy, other than local dermatological, for the previous 5 years.
- Signed informed consent before entry into the study.
Who cannot join
- Prior hormonal treatment for prostate cancer within 6 months prior to study start.
- Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior to study start.
- Presence of another neoplastic lesion or brain metastases.
- Prior hypophysectomy or adrenalectomy.
- Known or suspicion of vertebral metastases with risk of spinal compression.
- Severe kidney or liver failure (creatinine > 2 times the upper normal limit, ASAT and ALAT >3 times the upper normal limit).
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- Any concomitant disorder or resulting therapy that is likely to interfere with patient compliance or with the study in the opinion of the Investigator.
- Participation in another study with an experimental drug within 3 months before study start or within 5 drug half-lives of the investigational drug (whichever is the longer).
- Known hypersensitivity to any of the test materials or related compounds.
- Known active use of recreational drug or alcohol dependence in the opinion of the Investigator.
- Any current use or use 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.
- Use of systemic or inhaled corticosteroids (topical application permitted).
- Use of anticoagulants: heparin and coumarine derivatives (acetylsalicylic acid permitted).
- Inability to give Informed Consent or to comply fully with the protocol.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Quintiles South Africa
Lyttelton Manor, Centurion, 0157
About this study
Official title: A Multicenter, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer.
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment >90% of the patients would achieve and maintain castrate levels of serum testosterone.
Read the detailed description
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.
- Conditions
- Prostatic Neoplasm
- Being tested
- triptorelin embonate (INN)
- Keywords
- triptorelin, 6-month formulation, advanced prostate cancer
- 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 embonate (INN)Drug
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin | Experimental | Not described Receives: Drug: triptorelin embonate (INN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Castration and Maintenance of Castration
Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).
Measured: at Day 29
Secondary outcomes (1)
LH Increase
% of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st \& 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts
Measured: day 1 and day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJul 2006
- Primary completionAug 2007
- Study completionAug 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751790
- Sponsor's protocol ID
- DEB-TRI6M-301
- Status last verified
- Aug 2012
- First submitted
- 11 Sep 2008
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lundstrom EA, Rencken RK, van Wyk JH, Coetzee LJ, Bahlmann JC, Reif S, Strasheim EA, Bigalke MC, Pontin AR, Goedhals L, Steyn DG, Heyns CF, Aldera LA, Mackenzie TM, Purcea D, Grosgurin PY, Porchet HC. Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study. Clin Drug Investig. 2009;29(12):757-65. doi: 10.2165/11319690-000000000-00000.
PubMed 19888782
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00751790
- Acronym / sponsor ID
- DEB-TRI6M-301
- Conditions
- Prostatic Neoplasm
- Keywords
- triptorelin, 6-month formulation, advanced prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Posted 13 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment >90% of the patients would achieve and maintain castrate levels of serum testosterone.
Detailed description
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triptorelin | Experimental | Drug: triptorelin embonate (INN) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically proven prostate cancer.
- The prostate cancer should be staged T3-4NxMx or TxN1-3Mx or TxNxM1 according to the TNM classification or the patient should have rising PSA after failed local therapy and be candidate for androgen deprivation therapy.
- Serum testosterone levels >5 nmol/L.
- Karnofsky performance index >40.
- Expected survival > 18 months.
Key exclusion criteria (14 listed)
- Prior hormonal treatment for prostate cancer within 6 months prior to study start.
- Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within 2 months prior to study start.
- Presence of another neoplastic lesion or brain metastases.
- Prior hypophysectomy or adrenalectomy.
- Known or suspicion of vertebral metastases with risk of spinal 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 embonate (INN)Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks | Drug | Triptorelin |
Primary outcome
Achievement of Castration and Maintenance of Castration
Time frame: at Day 29
Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).
1 secondary outcome
LH Increase
Time frame: day 1 and day 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19888782Lundstrom EA, Rencken RK, van Wyk JH, Coetzee LJ, Bahlmann JC, Reif S, Strasheim EA, Bigalke MC, Pontin AR, Goedhals L, Steyn DG, Heyns CF, Aldera LA, Mackenzie TM, Purcea D, Grosgurin PY, Porchet HC. Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study. Clin Drug Investig. 2009;29(12):757-65. doi: 10.2165/11319690-000000000-00000.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing triptorelin embonate (INN) in people with Prostatic Neoplasm, run by Debiopharm International SA at 1 site in South Africa.
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 14 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 25 Jul 2014. 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 South Africa. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Jun 2012). 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?
Achievement of Castration and Maintenance of Castration (time frame: at Day 29). 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 NCT00751790, 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 25 Jul 2014.