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

NCT00751790 | Completed Phase 3 Results

• 1 other identifier: DEB-TRI6M-301
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm

Keywords

triptorelin, 6-month formulation, advanced prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• LH Increase

  day 1 and day 169

Study Arms (1)

Triptorelin

EXPERIMENTAL

Drug: triptorelin embonate (INN)

Interventions

triptorelin embonate (INN) DRUG

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

Triptorelin

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (1)

Quintiles South Africa

Lyttelton Manor, Centurion, 0157, South Africa

Location

Related Publications (1)

• 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.

  PMID: 19888782 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Eija Lundström
• Organization: Debiopharm S.A.

elundstrom@debiopharm.com

+41 21 3210111

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: July 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: July 25, 2014
• Results First Posted: June 13, 2012

Record last verified: 2012-08

Locations

ZA (1)