Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate (TriptoSwitch)

Ipsen

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Triptorelin embonate 22.5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05458856

D-FR-52014-245

2021-005719-29 (EudraCT Number)

Details and patient eligibility

About

The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.

Enrollment

147 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Participant is male and must be 18 years of age inclusive, at the time of signing the informed consent
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
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).
Has serum testosterone levels <1.735 nmol/L (50 ng/dL) at screening
Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
Has a life expectancy of >18 months
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
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria :

Presence of another neoplastic lesion or brain metastases
Metastatic hormone-sensitive prostate cancer with high tumour burden
Metastatic castration-resistant prostate cancer
Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance or with the study in the opinion of the investigator
Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the past 6 months
Planned intermittent scheme of GnRH analogue
At the time of screening, planned use of any chemotherapy for prostate cancer during the study
Prior hypophysectomy or adrenalectomy
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
Severe kidney or liver failure (creatinine >2 times the normal range, aspartate aminotransferase and alanine aminotransferase >3 times the normal range)
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
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
Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues
Known active use of recreational drug or alcohol dependence in the opinion of the investigator
Inability to give informed consent or to comply fully with the protocol