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Advanced Prostate CancerPhase 3NCT05590793

Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate

A Phase 3 study testing Triptorelin pamoate (embonate) salt in people with Advanced Prostate Cancer and Metastatic Prostate Cancer, run by Ipsen at 36 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main aim of this study is to assess the effectiveness and safety of the 6-month formulation of triptorelin pamoate in Chinese participants with locally advanced or metastatic cancer of the prostate. Participants will receive 1 injection of triptorelin pamoate 6-month formulation. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Triptorelin pamoate (embonate) salt
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
36 sitesChina
Study dates
17 Nov 2022to 20 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is capable of giving signed informed consent
  • Participant must be over 18 years of age, at the time of signing the informed consent.
  • Has a histologically or cytologically confirmed adenocarcinoma, locally advanced or metastatic prostate cancer. Or participant has PSA recurrence after curative treatment and be a candidate for androgen deprivation therapy (ADT).
  • Has serum testosterone level >150 ng/dL (> 5.2 nmol/L).
  • Has expected survival time ≥12 months according to the investigator's assessment.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status score ≤1

Who cannot join

  • Risk of a serious complication in the case of tumour flare
  • Presence of another neoplastic lesion or brain metastases.
  • 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.
  • Metastatic hormone-sensitive prostate cancer with high tumour burden.
  • Metastatic castration-resistant prostate cancer.
  • Previous surgical castration.
Show all 18Show fewer
  • Previous hormone therapy (including abiraterone) for prostate cancer within 6 months prior to study start.
  • Previous cytotoxic chemotherapy treatment within 6 months prior to study screening.
  • Use of finasteride or dutasteride within 2 months prior to study screening.
  • Previous hypophysectomy or adrenalectomy
  • Any current use or use within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and antiandrogens.
  • Current use of systemic or inhaled corticosteroids (topical application permitted).
  • Any previous use of traditional Chinese medicine or herbal products within 1 month prior to study screening or planned use during the study of products, which are known to have cytotoxic effect or affect the metabolism and/or secretion of androgenic hormones
  • Participation in another study with an investigational drug or treatment within 3 months prior to study screening or within 5 drug half-lives of the investigational drug (whichever is the longer).
  • Severe kidney or liver impairment (creatinine >2 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >3 x ULN).
  • Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance, the i.m. administration of the drug or with the study in the opinion of the investigator.
  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

China36 sites

  • Affiliated Hospital of Hebei University

    Baoding

  • Beijing Hospital

    Beijing

  • Peking University First Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • Hunan Cancer Hospital

    Changsha

  • West China Hospital of Sichuan University

    Chengdu

  • Chongqing University Cancer Hospital

    Chongqing

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Deyang People's Hospital

    Deyang

  • Sun Yat-Sen University Cancer Center

    Guangzhou

  • Guizhou Provincial People's Hospital

    Guiyang

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • Qilu Hospital of Shandong University

    Jinan

  • Shandong Provincial Hospital

    Jinan

  • Nanjing Drum Tower Hospital

    Nanjing

  • Zhongda Hospital Southeast University

    Nanjing

  • Ningbo First Hospital

    Ningbo

  • Fudan University Shang Hai Cancer Center

    Shanghai

  • Shanghai Fifth People's Hospital

    Shanghai

  • Shanghai Tongji Hospital

    Shanghai

  • Liaoning Cancer Hospital & Institute

    Shenyang

  • The First Hospital of China Medical University

    Shenyang

  • Peking University Shenzhen Hospital

    Shenzhen

  • Suining Central Hospital

    Suining

  • The Second Affiliated Hospital of Soochow University

    Suzhou

  • Tianjin Cancer Hospital

    Tianjin

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu

  • Wuxi People's Hospital

    Wuxi

  • Northern Jiangsu People's Hospital

    Yangzhou

  • Subei People's Hospital

    Yangzhou

  • Yantai Yuhuangding Hospital

    Yantai

  • Henan Cancer Hospital

    Zhengzhou

  • Zigong First People's Hospital

    Zigong

Other trials in China

About this study

Official title: A Multicentre, Open-label, Single-arm Study to Investigate the Efficacy and Safety of Triptorelin Pamoate 22.5 mg 6-month Formulation in Chinese Patients With Locally Advanced or Metastatic Prostate Cancer

The main aim of this study is to assess the effectiveness and safety of the 6-month formulation of triptorelin pamoate in Chinese participants with locally advanced or metastatic cancer of the prostate. Participants will receive 1 injection of triptorelin pamoate 6-month formulation.

Being tested
Triptorelin pamoate (embonate) salt
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triptorelin pamoate (embonate) saltDrug

    Also called Dipherelin

    Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.

Study groups in NCT05590793
Study groupRoleWhat they receive
Triptorelin pamoate 22.5 mg 6-month formulationExperimentalAll enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1.
Receives: Drug: Triptorelin pamoate (embonate) salt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29

    Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Achievement of testosterone castration was defined as serum testosterone level <50 nanograms per deciliter (ng/dL) or 1.735 nanomoles/liter (nmol/L). Percentages are rounded off to the tenth decimal place.

    Measured: Day 29

  2. Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24

    Blood samples were collected to determine the serum testosterone concentrations using a validated, specific and sensitive LC-MS/MS method. Maintenance of castration was defined as serum testosterone level <50 ng/dL or 1.735 nmol/L.

    Measured: From Week 8 to Week 24

Secondary outcomes (11)

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events of Local Tolerance

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, or any other medically important event. TEAEs were AEs with start date on or after the date of study intervention administration and up to 24 weeks after date of first dose of treatment. Local tolerance was assessed 2 hours (+/-15 minutes) after the single injection of 6-month formulation triptorelin by examination of injection site for signs including but not limited to tenderness, erythema, swelling, hematoma, rash, pain, itching and induration.

    Measured: From the first dose of study intervention (Day 1) up to end of study visit (Week 24), approximately 169 days

  2. Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24

    Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of difference between the PSA values at Week 12 and Week 24 and the baseline value divided by the baseline value. Baseline was defined as the last non-missing measurement taken prior to first study intervention administration.

    Measured: Baseline (Day 1), Weeks 12 and 24

  3. Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate

    Blood samples were collected at specified timepoints for the assessment of tmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

    Measured: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169

  4. Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate

    Blood samples were collected at specified timepoints for the assessment of Cmax of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

    Measured: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169

  5. Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate

    Blood samples were collected at specified timepoints for the assessment of AUC0-169 of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

    Measured: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169

  6. Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate

    Blood samples were collected at specified timepoints for the assessment of AUClast of triptorelin pamoate. The PK parameters were performed using non-compartmental analysis.

    Measured: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 and 168 hours post-dose on Day 1, Days 15, 22, 29, 57, 85, 113, 141 and 169

  7. Time to Maximum Observed Plasma Concentration of Testosterone

    Blood samples were collected at specified timepoints for the assessment of tmax of testosterone. The PD parameters were performed using non-compartmental analysis.

    Measured: Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

  8. Maximum Observed Plasma Concentration of Testosterone

    Blood samples were collected at specified timepoints for the assessment of Cmax of testosterone. The PD parameters were performed using non-compartmental analysis.

    Measured: Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

  9. Time to Castration of Testosterone

    Blood samples were collected at specified timepoints for the assessment of tcast of testosterone. tcast was defined as time to reach serum testosterone level <50 ng/dL or 1.735 nmol/L. The PD parameters were performed using non-compartmental analysis.

    Measured: Pre-dose on Day 1 and Days 2, 3, 5, 8, 15, 22, 29, 57, 85, 113, 141 and 169

  10. Plasma Concentrations of Triptorelin Pamoate

    Blood samples were collected at specified timepoints for the assessment of plasma concentration of triptorelin pamoate.

    Measured: Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24

  11. Serum Concentrations of Testosterone

    Blood samples were collected at specified timepoints for the assessment of serum concentration of testosterone.

    Measured: Pre-dose on Day 1 and post-dose at Weeks 4, 8, 12, 16, 20 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start17 Nov 2022
  3. Primary completion20 Aug 2024
  4. Study completion20 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05590793
Sponsor's protocol ID
D-CN-52014-237
Other IDs
CTR20221796
Status last verified
Aug 2025
First submitted
14 Oct 2022
Last updated
9 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptorelin pamoate (embonate) salt in people with Advanced Prostate Cancer and Metastatic Prostate Cancer, run by Ipsen at 36 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29 (time frame: Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05590793.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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