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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name TriptoSwitch

NCTNCT05458856 (opens ClinicalTrials.gov in a new tab)Other idD-FR-52014-245Other id2021-005719-29

Overview

Status
Completed
Phase
Phase 3
Enrollment
147 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
7 countries

Belgium, Czechia, France, Germany, Lithuania, Netherlands, Spain

Start
30 Aug 2022
Primary completion
8 Jul 2024
Completion
8 Jul 2024
First posted
14 Jul 2022
Last update posted
25 Jul 2025
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 3

    TriptoSwitch

    NCT05458856

    30 Aug 2022 to 8 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Triptorelin embonate 22.5 mgDrug

Arms1

  • Experimental

    Triptorelin embonate

    All participants will receive triptorelin embonate 22.5 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study

    Time frame · Up to Day 337

    Registry description

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Maintenance of castration during the study was defined as testosterone \<1.735 nanomoles per liter (nmol/L) (\<50 nanograms/deciliter \[ng/dL\]) at Days 29, 85, 141, 169, 253, 309 and 337.

Secondary outcomes(6)
  1. Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337

    Time frame · Days 29, 85, 141, 169, 253, 309 and 337

    Registry description

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \<1.735 nmol/L (\<50 ng/dL).

  2. Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study

    Time frame · Up to Day 337

    Registry description

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.

  3. Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337

    Time frame · Days 29, 85, 141, 169, 253, 309 and 337

    Registry description

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.

  4. Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169

    Time frame · On Days 3, 7, 171, and 175

    Registry description

    Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \<1.735 nmol/L (\<50 ng/dL).

  5. Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337

    Time frame · Baseline (prior to injection on Day 1), Days 169 and 337

    Registry description

    Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of the difference between the PSA values at Days 169 and 337 and the baseline value divided by the baseline value. The baseline value was the last sample prior to the first injection.

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance

    Time frame · From first dose of study treatment (Day 1) up to end of study visit (Day 337)

    Registry description

    An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs were AEs that started or worsened on or after the first study treatment administration and within 168 days after the last dose of study treatment, or up to Day 337, whichever was later. Local tolerance was assessed 2 hours after each injection by examination of injection site for signs such as but not limited to tenderness, redness, bruising, erythema, swelling, rash, pain, itching, induration, hematoma, ulceration or necrosis.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to Day 337

Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study

GroupValue (percentage of participants)
Triptorelin Embonate 22.5 mg95.0
Secondary and other outcome results(6)
Secondary outcomeNumber· Days 29, 85, 141, 169, 253, 309 and 337

Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337

GroupValue (percentage of participants)
Triptorelin Embonate 22.5 mg100.0
Secondary outcomeNumber· Up to Day 337

Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study

GroupValue (percentage of participants)
Triptorelin Embonate 22.5 mg83.3
Secondary outcomeNumber· Days 29, 85, 141, 169, 253, 309 and 337

Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337

GroupValue (percentage of participants)
Triptorelin Embonate 22.5 mg92.5
Secondary outcomeNumber· On Days 3, 7, 171, and 175

Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169

GroupValue (percentage of participants)
Triptorelin Embonate 22.5 mg92.5
Secondary outcomeMedian· Baseline (prior to injection on Day 1), Days 169 and 337

Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337

GroupValue (percent change)
Triptorelin Embonate 22.5 mg0.00
Secondary outcomeCount of participants· From first dose of study treatment (Day 1) up to end of study visit (Day 337)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance

GroupValue (Participants)
Triptorelin Embonate 22.5 mg88

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Triptorelin Embonate 22.5 mgParticipants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.4 / 14526 / 14538 / 145

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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