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

Primary Purpose

Prostatic Neoplasm

Status

Completed

Phase

Phase 3

Locations

South Africa

Study Type

Interventional

Intervention

triptorelin embonate (INN)

About this trial

This is an interventional treatment trial for Prostatic Neoplasm focused on measuring triptorelin, 6-month formulation, advanced prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Quintiles South Africa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triptorelin

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00751790

First Posted

September 11, 2008

Last Updated

July 17, 2014

Sponsor

Debiopharm International SA

1. Study Identification

Unique Protocol Identification Number

NCT00751790

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Debiopharm International SA

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasm

Keywords

triptorelin, 6-month formulation, advanced prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Triptorelin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

triptorelin embonate (INN)

Intervention Description

Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks

Primary Outcome Measure Information:

Title

Achievement of Castration and Maintenance of Castration

Description

Time Frame

at Day 29

Secondary Outcome Measure Information:

Title

LH Increase

Description

Time Frame

day 1 and day 169

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Quintiles South Africa

City

Lyttelton Manor

State/Province

Centurion

ZIP/Postal Code

0157

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

19888782

Citation

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.

Results Reference

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

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