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New 6-Month shot shows promise for prostate cancer control

NCT ID NCT05590793

Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a single injection of triptorelin pamoate that lasts 6 months in 195 Chinese men with advanced or metastatic prostate cancer. The goal was to lower testosterone to castrate levels, which helps slow cancer growth. Results showed the injection effectively reduced and maintained low testosterone levels, with manageable side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
triptorelin pamoate (a hormone-blocking drug)
What this could lead to
If successful, this could offer a convenient 6-month injection option for managing advanced prostate cancer in Chinese patients.
What could go wrong
This is a single-arm, open-label study without a comparison group, so results may not be definitive. Side effects from hormone suppression are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

195 people

The number who actually took part.

Started

Nov 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : * 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 Exclusion Criteria : * 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. * 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.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced prostate cancer Locally advanced prostate cancer Metastatic prostate cancer

Contacts and locations

Locations

  • Affiliated Hospital of Hebei University

    Baoding, China

  • Beijing Hospital

    Beijing, China

  • Chongqing University Cancer Hospital

    Chongqing, China

  • Deyang People's Hospital

    Deyang, China

  • Fudan University Shang Hai Cancer Center

    Shanghai, China

  • Guizhou Provincial People's Hospital

    Guiyang, China

  • Henan Cancer Hospital

    Zhengzhou, China

  • Hunan Cancer Hospital

    Changsha, China

  • Liaoning Cancer Hospital & Institute

    Shenyang, China

  • Nanjing Drum Tower Hospital

    Nanjing, China

  • Ningbo First Hospital

    Ningbo, China

  • Northern Jiangsu People's Hospital

    Yangzhou, China

  • Peking University First Hospital

    Beijing, China

  • Peking University People's Hospital

    Beijing, China

  • Peking University Shenzhen Hospital

    Shenzhen, China

  • Qilu Hospital of Shandong University

    Jinan, China

  • Shandong Provincial Hospital

    Jinan, China

  • Shanghai Fifth People's Hospital

    Shanghai, China

  • Shanghai Tongji Hospital

    Shanghai, China

  • Subei People's Hospital

    Yangzhou, China

  • Suining Central Hospital

    Suining, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, China

  • The First Hospital of China Medical University

    Shenyang, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, China

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, China

  • Tianjin Cancer Hospital

    Tianjin, China

  • West China Hospital of Sichuan University

    Chengdu, China

  • Wuxi People's Hospital

    Wuxi, China

  • Yantai Yuhuangding Hospital

    Yantai, China

  • Zhongda Hospital Southeast University

    Nanjing, China

  • Zigong First People's Hospital

    Zigong, China

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