Clinical trial NCT01673984: GP Extended Action Triptorelin
Official title: A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Maintaining Biochemical Castration
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.
timeFrame: 12 months
measure: Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
timeFrame: 6 and 12 months
measure: Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.
timeFrame: Baseline and Month 12
measure: Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
timeFrame: 6 and 12 month
measure: Patient Satisfaction With Treatment.
timeFrame: Month 12
measure: Percentage of Participants Who Changed Injection Frequency After Completion of the Study
timeFrame: Month 12
Other outcomes:
Locations:
city: Addlestone
country: United Kingdom
facility: The Crouch Oak Family Practice
city: Ashford
country: United Kingdom
facility: Dr Carter & Partners
city: Aylesbury
country: United Kingdom
facility: Westongrove Research Centre, Aston Clinton Surgery
city: Bath
country: United Kingdom
facility: Clinical Research Unit, Oldfield Surgery
city: Bath
country: United Kingdom
facility: Clinical Research Unit, The Pulteney Practice
city: Bath
country: United Kingdom
facility: St James' Surgery
city: Blackpool
country: United Kingdom
facility: Waterloo Medical Centre
city: Bury St. Edmunds
country: United Kingdom
facility: Woolpit Health Centre
city: Canterbury
country: United Kingdom
facility: Cossington House Surgery
city: Chesterfield
country: United Kingdom
facility: Research Office, Avondale Surgery
city: Chippenham
country: United Kingdom
facility: Clinical Research Dept., Rowden Surgery
city: Chippenham
country: United Kingdom
facility: Clinical Research Unit, Hathaway Medical Centre
city: Corsham
country: United Kingdom
facility: The Porch Surgery
city: Crawley
country: United Kingdom
facility: Pound Hill Surgery
city: East Horsley
country: United Kingdom
facility: The Medical Centre
city: Hinckley
country: United Kingdom
facility: Burbage Surgery
city: Hitchin
country: United Kingdom
facility: The Portmill Surgery
city: Irvine
country: United Kingdom
facility: Townhead Surgery
city: Leamington Spa
country: United Kingdom
facility: Sherbourne Medical Centre
city: Mortimer Common
country: United Kingdom
facility: Mortimer Surgery
city: Nantwich
country: United Kingdom
facility: Kiltearn Medical Centre
city: Northampton
country: United Kingdom
facility: Danes Camp Surgery
city: Northampton
country: United Kingdom
facility: Kingsthorpe Medical Centre
city: Penzance
country: United Kingdom
facility: Cape Cornwall Surgery
city: Penzance
country: United Kingdom
facility: The Alverton Practice
city: Peterborough
country: United Kingdom
facility: Wansford & Kings Cliffe Practice, Wansford Surgery
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
city: Plymouth
country: United Kingdom
facility: The Rame Group Practice
city: Sandbach
country: United Kingdom
facility: Ashfields Primary Care Centre
city: St Austell
country: United Kingdom
facility: Brannel Surgery
city: Sunbury-on-Thames
country: United Kingdom
facility: Sunbury Health Centre Group Practice
city: Trowbridge
country: United Kingdom
facility: Adcroft Surgery
city: Watford
country: United Kingdom
facility: Sheepcot Medical Centre
city: Wellingborough
country: United Kingdom
facility: Albany House Medical Centre
city: Wokingham
country: United Kingdom
facility: Woosehill Medical Centre
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: