Primary outcomeNumber· at Day 29
Achievement of Castration and Maintenance of Castration
| Group | Value (percentage of enrolled patients) |
|---|---|
| Triptorelin | 97.5 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
NCTNCT00751790 (opens ClinicalTrials.gov in a new tab)Other idDEB-TRI6M-301
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 120 participants (actual)
- Sponsor
- Debiopharm International SA · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
South Africa
- Start
- Jul 2006
- Primary completion
- Aug 2007
- Completion
- Aug 2007
- First posted
- 12 Sept 2008 (estimated)
- Last update posted
- 25 Jul 2014 (estimated)
- Conditions
- Prostatic Neoplasm
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200620072008
- Ph 3
Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
NCT00751790Jul 2006 to Aug 2007
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- triptorelin embonate (INN)Drug
Arms1
Experimental
Triptorelin
Primary outcomes1
Outcomes the sponsor listed as primary.
Achievement of Castration and Maintenance of Castration
Time frame · at Day 29
Registry description
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).
Secondary outcomes(1)
LH Increase
Time frame · day 1 and day 169
Registry description
% 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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeNumber· day 1 and day 169
LH Increase
| Group | Value (patient) |
|---|
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| TriptorelinEach subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks | – | 17 / 120 | 115 / 120 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Clinical trial · 2009
5 results
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.
Lundström et al. 2009Clinical drug investigationcited by 46
PMID 19888782DOI 10.2165/11319690-000000000-00000PUB-19888782
Full text at the publisher5 results
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- Not stated
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
* 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.
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