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

Prostatic Neoplasm Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751790
• Other study ID #: DEB-TRI6M-301
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2008
• Last updated: July 17, 2014
• Start date: July 2006
• Est. completion date: August 2007

Study information

• Verified date: August 2012
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• triptorelin embonate (INN)
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks

Locations

Country	Name	City	State
South Africa	Quintiles South Africa	Lyttelton Manor	Centurion

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	at Day 29	No
Secondary	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	day 1 and day 169	No