GP Extended Action Triptorelin

NCT01673984 | Terminated Phase 4 Results

• 2 other identifiers: A-97-52014-1812011-004213-16
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 35

Brief Summary

The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Biochemical Castration

  Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.

  6 months

Secondary Outcomes (6)

• Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.

  12 months

• Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels

  6 and 12 months

• Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.

  Baseline and Month 12

• Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)

  6 and 12 month

• Patient Satisfaction With Treatment.

  Month 12

Study Arms (2)

Decapeptyl® SR 22.5mg (Triptorelin)

EXPERIMENTAL

Drug: Decapeptyl® SR 22.5mg

Current 3-monthly LHRH agonist

ACTIVE COMPARATOR

One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg

Drug: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg

Interventions

Decapeptyl® SR 22.5mg DRUG

22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).

Also known as: Triptorelin

Decapeptyl® SR 22.5mg (Triptorelin)

Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg DRUG

For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall

Also known as: Triptorelin

Current 3-monthly LHRH agonist

Eligibility Criteria

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

You may qualify if:

• Patients must give written (personally signed and dated) informed consent before completing any study related procedure.
• Patients must be 18 years old or over.
• Patients must have a documented diagnosis of locally advanced or metastatic prostate cancer suitable for hormonal treatment
• Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL
• Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the screening tests
• Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels between screening and baseline (i.e. the baseline value must either be lower or less than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the screening value).
• In addition:
• For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any formulation) must have been initiated within the last 3 years from Baseline,
• For patients with metastatic prostate cancer (M+) and a Gleason score
• ≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last 2 years from Baseline,
• For patients with metastatic prostate cancer (M+) and a Gleason score \> 7, LHRH agonist injection (any formulation) must have been initiated within the last 12 months from Baseline.
• Patients must have an estimated life expectancy of at least twelve months according to the investigator's assessment.

You may not qualify if:

• Patients have had previous surgical castration or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
• Patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions.
• Patients have received investigational drug(s) or treatment(s) within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
• Patients have had a diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal cell carcinoma.
• Patients currently taking additional anti-androgen therapy as part of an active hormonal control therapy.
• Patients scheduled to receive palliative radiotherapy during the course of the study.
• Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to radiotherapy.
• Patients receiving LHRH agonist as adjuvant to surgery.
• Patients scheduled to undergo radical prostatectomy during the course of the study.
• Patients with known hypersensitivity to LHRH agonists, their analogues or any or any other component of the products to be administered.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (35)

The Crouch Oak Family Practice

Addlestone, United Kingdom

Location

Dr Carter & Partners

Ashford, United Kingdom

Location

Westongrove Research Centre, Aston Clinton Surgery

Aylesbury, United Kingdom

Location

Clinical Research Unit, Oldfield Surgery

Bath, United Kingdom

Location

Clinical Research Unit, The Pulteney Practice

Bath, United Kingdom

Location

St James' Surgery

Bath, United Kingdom

Location

Waterloo Medical Centre

Blackpool, United Kingdom

Location

Woolpit Health Centre

Bury St Edmunds, United Kingdom

Location

Cossington House Surgery

Canterbury, United Kingdom

Location

Research Office, Avondale Surgery

Chesterfield, United Kingdom

Location

Clinical Research Dept., Rowden Surgery

Chippenham, United Kingdom

Location

Clinical Research Unit, Hathaway Medical Centre

Chippenham, United Kingdom

Location

The Porch Surgery

Corsham, United Kingdom

Location

Pound Hill Surgery

Crawley, United Kingdom

Location

The Medical Centre

East Horsley, United Kingdom

Location

Burbage Surgery

Hinckley, United Kingdom

Location

The Portmill Surgery

Hitchin, United Kingdom

Location

Townhead Surgery

Irvine, United Kingdom

Location

Mortimer Surgery

Mortimer Common, United Kingdom

Location

Kiltearn Medical Centre

Nantwich, United Kingdom

Location

Danes Camp Surgery

Northampton, United Kingdom

Location

Kingsthorpe Medical Centre

Northampton, United Kingdom

Location

Cape Cornwall Surgery

Penzance, United Kingdom

Location

The Alverton Practice

Penzance, United Kingdom

Location

Wansford & Kings Cliffe Practice, Wansford Surgery

Peterborough, United Kingdom

Location

Knowle House Surgery

Plymouth, United Kingdom

Location

The Rame Group Practice

Plymouth, United Kingdom

Location

Sherbourne Medical Centre

Royal Leamington Spa, United Kingdom

Location

Ashfields Primary Care Centre

Sandbach, United Kingdom

Location

Brannel Surgery

St Austell, United Kingdom

Location

Sunbury Health Centre Group Practice

Sunbury-on-Thames, United Kingdom

Location

Adcroft Surgery

Trowbridge, United Kingdom

Location

Sheepcot Medical Centre

Watford, United Kingdom

Location

Albany House Medical Centre

Wellingborough, United Kingdom

Location

Woosehill Medical Centre

Wokingham, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate; Goserelin

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: Medical Director, Uro-Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 23, 2025
• Results First Posted: September 29, 2015

Record last verified: 2025-05

Locations

GB (35)