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Prostate CancerPhase 3DKP 3M SCNCT01715129

Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer

A Phase 3 study testing Triptorelin Pamoate 11.25mg in people with Prostate Cancer, run by Ipsen at 12 sites in 5 countries.

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

Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Triptorelin Pamoate 11.25mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
12 sitesin 5 countries
Study dates
Jan 2013to Oct 2013
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

  • Histologically proven locally advanced or metastatic prostate cancer who are suitable for androgen deprivation therapy
  • Male aged ≥18 years old
  • Screening testosterone level of >125 ng/dL
  • Life expectancy of greater than 12 months in the judgement of the Investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Willing to give signed informed consent freely
  • Able to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • Prior hormonal therapy for prostate cancer
  • Prior surgery or radiotherapy of prostate cancer with curative intent unless disease is verified by a rising prostate specific antigen (PSA) concentration on follow up (elevated PSA values on last two tests conducted at least a month apart) and the patient is eligible for androgen deprivation therapy
  • Presence or history of any other malignancy except for non melanoma skin cancer adequately treated at least 2 years before study entry
  • Painful local bone lesions or spinal lesions which may lead to compression
  • History of myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, Class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within six months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and untreated atrial or uncontrolled ventricular arrhythmias
  • Any condition in opinion of the Investigator, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study, compromises the objective of the study or places the patient at unacceptable risk if he participates in the study
Show all 18Show fewer
  • Abnormal haematological, hepatic or renal functions:
  • Haemoglobin <9 g/dL, absolute neutrophil count ≤1.5 x 10^9/L or platelets ≤100 x 10^9/L
  • Serum creatinine ≥1.5 times the upper limit of normal (ULN)
  • Aspartate aminotransferase or alanine aminotransferase >2.5 times the ULN
  • Known hypersensitivity to the study treatment, to any of its excipients
  • Known active use of recreational drug or alcohol dependence in the opinion of the Investigator
  • Any current use or use within six months prior to start of treatment, of medications which are known to affect the metabolism and/or secretion of androgenic hormones: e.g. ketoconazole, aminoglutethimide, oestrogens, and progesterone
  • Use of systemic corticosteroids (inhaled corticosteroids and topical application of corticosteroids are permitted)
  • Aged ≥90 years for the main study and ≥80 years for those included in the pharmacokinetic (PK) patient population
  • Participation in any other study or receipt of any investigational compound in the 30 days (or five times the elimination half life if this is longer) prior to study entry
  • Any skin or other condition that may preclude s.c. injection administration
  • Known brain or epidural metastases.

Trial locations and contacts

12 sites in 5 countries.

12 sites in 5 countries

Bulgaria4 sites

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Shumen

  • Study site

    Varna

Other trials in Bulgaria

Poland3 sites

  • Study site

    Kutno

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Latvia2 sites

  • Study site

    Daugavpils

  • Study site

    Riga

Other trials in Latvia

Romania2 sites

  • Study site

    Bucharest

  • Study site

    Craiova

Other trials in Romania

France1 site

  • Study site

    Suresnes

Other trials in France

About this study

Official title: A Phase III Single Arm Study to Evaluate the Efficacy, Safety and Local Tolerability of a Subcutaneous 3-month Formulation of Triptorelin Pamoate (11.25 mg) in Patients With Locally Advanced or Metastatic Prostate Cancer

Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.

Conditions
Prostate Cancer
Being tested
Triptorelin Pamoate 11.25mg
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 11.25mgDrug

Study groups in NCT01715129
Study groupRoleWhat they receive
11.25mgExperimental11.25mg, SC on Day 1 and Day 92
Receives: Drug: Triptorelin Pamoate 11.25mg

What is being measured

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

  1. Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183

    Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183

    Measured: At Day 29 and 183

Secondary outcomes (13)

  1. Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose

    Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.

    Measured: At Day 92

  2. Probability of Testosterone <50 ng/dL

    Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.

    LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry

    Measured: Day 29 through Day 183

  3. Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95

    Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.

    Measured: Day 95

  4. Time to Achieve Castration (Tcast)

    Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)

    Measured: Up to Day 36

  5. Plasma Triptorelin Levels (Cmin)

    Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.

    Measured: At Day 92 and 183

  6. Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects

    Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.

    Measured: From Day 1 (Baseline) to Day 183 (End of study)

  7. Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)

    0-4 ng/mL (normal PSA value)

    >4 ng/mL (abnormal PSA levels)

    Measured: At Day 183

  8. Clinically Apparent Tumor Progression

    Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).

    Measured: Day 92 and 183

  9. Percentage of Subjects With Adverse Events

    Measured: Up to Day 183

  10. Time to Cmax (Tmax) of Triptorelin

    Measured: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1

  11. Peak Plasma Concentration Value (Cmax) of Triptorelin

    Measured: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1

  12. Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin

    Measured: At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1

  13. Cmin of Triptorelin in Subset of 18 Subjects

    Measured: At Day 92 and 183

Timeline

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

  1. First posted26 Oct 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionOct 2013
  4. Study completionOct 2013

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
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01715129
Sponsor's protocol ID
8-55-52014-200
Other IDs
2012-001279-35
Acronym
DKP 3M SC
Status last verified
Nov 2019
First submitted
24 Oct 2012
Last updated
9 Dec 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptorelin Pamoate 11.25mg in people with Prostate Cancer, run by Ipsen at 12 sites in 5 countries.

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 7 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 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Bulgaria, Poland, Latvia, Romania, France. 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 28 Oct 2015). 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 Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183 (time frame: At Day 29 and 183). 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 NCT01715129.

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 Dec 2019.

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