Prostate CancerPhase 3NCT01656161

Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

A Phase 3 study testing Triptorelin embonate 22.5 mg in people with Prostate Cancer, run by Debiopharm International SA at 10 sites in South Africa.

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 primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in: achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days after investigational medicinal product (IMP) injection], and… Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Triptorelin embonate 22.5 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 10 sitesSouth Africa
Study dates: Jul 2012to Aug 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 Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Summary Inclusion Criteria:

Meets protocol-specified criteria for qualification and contraception
Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Summary Exclusion Criteria:

Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

South Africa10 sites

New Groote Schuur Hospital, Division of Urology
Cape Town, 7925
JCM Bahlmann
George, Eastern Cape, 6530
East Rand Urology Research Unit, Clinix Private Clinic
Johannesburg, Gautang, 1475
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, 1619
Wilmed Park Hospital
Klerksdorp, North West, 2571
Paarl Medical Centre
Paarl, Cape Town, Western Cape, 7646
Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
Pretoria, Gauteng, 0002
Pretoria Urology Hospital
Pretoria, Gauteng, 0028
Vergelegen Medi-Clinic
Somerset West, Cape Town, 7130
Department of Urology, Tygerberg Hospital
Tygerberg, Cape Town, 7505

Other trials in South Africa

About this study

Official title: A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer

The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in:

achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days after investigational medicinal product (IMP) injection], and
in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Conditions: Prostate Cancer
Being tested: Triptorelin embonate 22.5 mg
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 embonate 22.5 mgDrug
Also called Pamorelin

Study groups in NCT01656161
Study group	Role	What they receive
Triptorelin embonate 22.5 mg	Experimental	Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169. Receives: Drug: Triptorelin embonate 22.5 mg

What is being measured

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

Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
Measured: within 337 days

Secondary outcomes (10)

Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169
Measured: on Days 1 and 169
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
Measured: Baseline through Day 337
Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)
Measured: Day 171
Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
Measured: Days 1-169
Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
Measured: Days 1-169
Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
Measured: Days 1-169
Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
Measured: Days 1-169
Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
Measured: Days 1-169 and Days 169-337
Triptorelin PK Metrics for Both Injections: Cmax
Measured: Days 1-169 and Days 169-337
Triptorelin PK Metrics for Both Injections: Concentration 0 Hour
Measured: Days 1-169 and Days 169-337

Timeline

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

Jul 2012Aug 2013

First posted2 Aug 2012 (estimated)
Study startJul 2012
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01656161
Sponsor's protocol ID: Debio 8206-SC-301
Other IDs: KRA75538
Status last verified: Aug 2015
First submitted: 31 Jul 2012
Last updated: 15 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Klippel KF, Winkler CJ, Jocham D, Rubben H, Moser B, Gulati A. [Effectiveness and tolerance of 1 dosage forms (subcutaneous and intramuscular) of decapeptyl depot in patients with advanced prostate carcinoma]. Urologe A. 1999 May;38(3):270-5. doi: 10.1007/s001200050280. German.
PubMed 10407987
Tornoe CW, Agerso H, Senderovitz T, Nielsen HA, Madsen H, Karlsson MO, Jonsson EN. Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues. Br J Clin Pharmacol. 2007 Jun;63(6):648-64. doi: 10.1111/j.1365-2125.2006.02820.x. Epub 2006 Nov 10.
PubMed 17096678

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT01656161
Acronym / sponsor ID: Debio 8206-SC-301
Conditions: Prostate Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc.
Study start: Jul 2012
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 2 Aug 2012 (estimated)
Results: Posted 15 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in:

achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days after investigational medicinal product (IMP) injection], and
in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Triptorelin embonate 22.5 mg	Experimental	Drug: Triptorelin embonate 22.5 mgParticipants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Triptorelin embonate 22.5 mgAlso: Pamorelin	Drug	Triptorelin embonate 22.5 mg

Primary outcome

Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
Time frame: within 337 days

10 secondary outcomes

Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169
Time frame: on Days 1 and 169
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
Time frame: Baseline through Day 337
Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)
Time frame: Day 171
Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
Time frame: Days 1-169
Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
Time frame: Days 1-169
Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
Time frame: Days 1-169
Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
Time frame: Days 1-169
Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
Time frame: Days 1-169 and Days 169-337
Triptorelin PK Metrics for Both Injections: Cmax
Time frame: Days 1-169 and Days 169-337
Triptorelin PK Metrics for Both Injections: Concentration 0 Hour
Time frame: Days 1-169 and Days 169-337

Results and safety

Results posted to the registry on 15 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triptorelin Embonate 22.5 mg	120	113

Primary outcome: Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)

Time frame: within 337 days. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Triptorelin Embonate 22.5 mg n = 120
Achieving (by Day 29)	98.33 (94.11 to 99.80)
Maintaining (Day 57 to Day 337)	82.61 (74.43 to 89.04)

Population analysed: Intention to treat population

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triptorelin Embonate 22.5 mg	17 of 120 (14.2%)	117 of 120 (97.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10407987Klippel KF, Winkler CJ, Jocham D, Rubben H, Moser B, Gulati A. [Effectiveness and tolerance of 1 dosage forms (subcutaneous and intramuscular) of decapeptyl depot in patients with advanced prostate carcinoma]. Urologe A. 1999 May;38(3):270-5. doi: 10.1007/s001200050280. German.
Background: PubMed 17096678Tornoe CW, Agerso H, Senderovitz T, Nielsen HA, Madsen H, Karlsson MO, Jonsson EN. Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues. Br J Clin Pharmacol. 2007 Jun;63(6):648-64. doi: 10.1111/j.1365-2125.2006.02820.x. Epub 2006 Nov 10.
Company websiteLink provided by the sponsor.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eija Lundstrom, MD study director

Debiopharm SA

J. Bahlmann, MD principal investigator

Private Practitioner

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Triptorelin embonate 22.5 mg in people with Prostate Cancer, run by Debiopharm International SA at 10 sites in South Africa.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Africa. 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 15 Sep 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 Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L) (time frame: within 337 days). 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 NCT01656161, which also lists 2 linked publications.

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 15 Sep 2015.