CompletedNCT00751790Updated Jul 25, 2014Results posted

Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer

A Phase 3 interventional study of triptorelin embonate (INN) in Prostatic Neoplasm, sponsored by Debiopharm International SA. Completed at 1 site in South Africa. Open to male participants. Per ClinicalTrials.gov, last updated 2014-07-25.

Sponsored by Debiopharm International SA · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 120
Allocation: Not applicable
Sex: Male

Study 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 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 studied

Prostatic Neoplasm

Browse trials for

Prostatic Neoplasms 6,370

Keywords

triptorelin, 6-month formulation, advanced prostate cancer

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 120 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Debiopharm International SA is the lead sponsor of 50 studies on the registry; 6 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: Male
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 120 participants (actual)

Study arms

Experimental
Triptorelin
Drug: triptorelin embonate (INN)

Interventions

Drugtriptorelin embonate (INN)
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks

What researchers measure

Primary outcomes

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).
Time frame: at Day 29

Secondary outcomes

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
Time frame: day 1 and day 169

Results

Posted Jun 13, 2012

Participant flow

Participant flow — Overall Study
Milestone	Triptorelin
Started	120
Completed	115
Not completed	5
Withdrew: Lost to follow-up	1
Withdrew: Death	3
Withdrew: Withdrawal by subject	1

Outcome measures

PrimaryAchievement 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).

Time frame:: at Day 29
Reported as:: Number · percentage of enrolled patients

Achievement of Castration and Maintenance of Castration
percentage of enrolled patients	Triptorelin
Achievement of Castration and Maintenance of Castration	97.5

SecondaryLH 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

Time frame:: day 1 and day 169
Reported as:: Number · patient

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Triptorelin	—	17/120 (14.2%)	115/120 (95.8%)

Most frequent serious events

Showing 10 of 16

Most frequent serious events
Event	Triptorelin
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/120
Acute myocardial infarctionCardiac disorders	1/120
Angina pectorisCardiac disorders	1/120
Atrial flutterCardiac disorders	1/120
Myocardial infarctionCardiac disorders	1/120
Diabetes mellitusEndocrine disorders	1/120
PneumoniaInfections and infestations	1/120
skin lacerationInjury, poisoning and procedural complications	1/120
Soft tissue injuryInjury, poisoning and procedural complications	1/120
Metastases to boneNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/120

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	Triptorelin
Hot flushVascular disorders	87/120
InfluenzaInfections and infestations	19/120
HypertensionVascular disorders	17/120
Back painMusculoskeletal and connective tissue disorders	13/120
Erectile dysfunctionReproductive system and breast disorders	12/120
Urinary tract infectionRenal and urinary disorders	11/120
ArthralgiaMusculoskeletal and connective tissue disorders	9/120
Pain in extremityMusculoskeletal and connective tissue disorders	9/120
HeadacheNervous system disorders	9/120
Testicular atrophyReproductive system and breast disorders	9/120

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Triptorelin
<=18 years	0
Between 18 and 65 years	0
>=65 years	120

Age, Continuous
Age, Continuous(years)	Triptorelin
Mean	71.11 ± 8.46

Sex: Female, Male
Sex: Female, Male(Participants)	Triptorelin
Female	0
Male	120

Region of Enrollment
Region of Enrollment(participants)	Triptorelin
South Africa	120

Study locations

1 site

Quintiles South Africa
Lyttelton Manor, Centurion 0157, South Africa

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00751790
Lead sponsor: Debiopharm International SA
Responsible party: Sponsor
First posted: Sep 12, 2008
Start date: Jul 2006
Primary completion: Aug 2007
Completion: Aug 2007
Results posted: Jun 13, 2012
Last update: Jul 25, 2014

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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