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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00751790
• Date of registration: 11/09/2008
• Prospective Registration: No
• Primary sponsor: Debiopharm International SA
• Public title: Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
• Scientific 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.
• Date of first enrolment: July 2006
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00751790
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

South Africa

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasm

Intervention(s)

Drug: triptorelin embonate (INN)

Primary Outcome(s)

Achievement of Castration and Maintenance of Castration [Time Frame: at Day 29]

Secondary Outcome(s)

LH Increase [Time Frame: day 1 and day 169]

Secondary ID(s)

DEB-TRI6M-301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/06/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00751790