An open-label, multicentre, single arm study to assess the efficacy and safety of triptorelin 6-month formulation administered subcutaneously in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue
- Conditions
- Prostate cancerProstatic adenocarcinoma1003859710036958
- Registration Number
- NL-OMON53969
- Lead Sponsor
- Ipsen Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
1. Participant is male and must be 18 years of age inclusive, at the time of
signing the informed consent.
2. Participant has histologically or cytologically proven prostate cancer with
rising PSA after failed local therapy or metastatic disease, or requiring
radiotherapy, and be a candidate for long-term (i.e. >1 year) androgen
deprivation therapy.
3. Participant requires a GnRH analogue treatment for a minimum of 18 months,
of which a minimum of 3 months of GnRH analogue treatment has already been
provided prior to screening. (Note: participants must receive study
intervention on Day 1 in accordance with the treatment schedule of their
previously received GnRH analogue therapy).
4. Has serum testosterone levels <1.735 nmol/L (50 ng/dL) at screening.
5. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0
to 1 (see Appendix 10.4).
6. Has a life expectancy of >18 months.
7. Male participants must agree that, if their partner is at risk of becoming
pregnant (although highly unlikely in this study population), they will use an
effective method of contraception. The participant must agree to use the
contraception during the whole of the study and for 9 months after the last
dose of study intervention.
8. Capable of giving signed informed consent as described in Appendix 10.1
which includes compliance with the requirements and restrictions listed in the
informed consent form (ICF) and in this protocol
Medical conditions
1.Presence of another neoplastic lesion or brain metastases.
2.Metastatic hormone-sensitive prostate cancer with high tumour burden
3.Metastatic castration-resistant prostate cancer
4.Any concomitant disorder or resulting therapy that is likely to interfere
with participant compliance or with the study in the opinion of the
investigator.
Prior/concomitant therapy
5.Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the
past 6 months
6.Planned intermittent scheme of GnRH analogue
7.Use of any other therapy for prostate cancer during the study (e.g.
chemotherapy)
8.Prior hypophysectomy or adrenalectomy
Prior/concurrent clinical study experience
9.Participation in another study with an experimental drug within 3 months
before signing informed consent or within five half-lives of the
investigational drug (whichever was the longer), or any other type of medical
research.
Diagnostic assessments
10.Severe kidney or liver failure (creatinine >2 times the normal range,
aspartate aminotransferase and alanine aminotransferase >3 times the normal
range)
Other exclusions
11.Any concomitant disorder or resulting therapy that is likely to interfere
with participant*s compliance, the subcutaneous administration of the drug or
with the study in the opinion of the investigator.
12.Previous history of QT prolongation or concomitant use of medicinal products
known to prolong the QT interval or with a known risk of torsades de pointes
13.Known hypersensitivity to triptorelin or any of its excipients, GnRH, other
GnRH agonist/analogues.
14.Known active use of recreational drug or alcohol dependence in the opinion
of the investigator
15.Inability to give informed consent or to comply fully with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation<br /><br>administered subcutaneously in maintaining serum testosterone castrate levels<br /><br>in participants with advanced prostate cancer previously treated and castrated<br /><br>with a GnRH analogue.</p><br>
- Secondary Outcome Measures
Name Time Method