Prostate CancerPhase 3POSEIDONNCT01313273

Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients

A Phase 3 study testing Lanreotide, non steroidal anti androgens and LHRH-a and Non steroidal anti androgens and LHRH-a in people with Prostate Cancer, run by Ipsen at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non metastatic castrate resistant prostate cancer patients. 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?: Lanreotide, non steroidal anti androgens and LHRH-a and Non steroidal anti androgens and LHRH-a
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteItaly
Study dates: Jun 2011to Jun 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 diagnosis of prostate cancer
Evidence of PSA progression despite castrate levels of testosterone (<50 ng/dL) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (LHRH-a)
Patients with non-metastatic or stable metastatic disease
Chromogranin A elevation above normal range (confirmed by a second evaluation at least 1 week later) [cut off levels will be > 20 U/L for enzyme linked immunosorbent (ELISA) assay and > 100 ng/ml for immunoradiometric (IRMA) assay]

Who cannot join

Patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel)
First line treatment with antiandrogen in monotherapy
Visceral metastasis
Previous or concomitant treatment with a somatostatin analogue

Trial locations and contacts

1 site in 1 country.

Italy1 site

A.O. S. Luigi Gonzaga
Orbassano ( TO)

Other trials in Italy

About this study

Official title: Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels

Read the detailed description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Conditions: Prostate Cancer
Being tested: Lanreotide, non steroidal anti androgens and LHRH-a, Non steroidal anti androgens and LHRH-a
Medical subject headings: Prostatic Neoplasms

What participants receive

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

Lanreotide, non steroidal anti androgens and LHRH-aDrug
Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months.
Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression.
Non steroidal anti androgens and LHRH-aDrug
Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression

Study groups in NCT01313273
Study group	Role	What they receive
Arm A	Other	Not described Receives: Drug: Non steroidal anti androgens and LHRH-a
Arm B	Experimental	Not described Receives: Drug: Lanreotide, non steroidal anti androgens and LHRH-a

What is being measured

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

Progression-free Survival
Measured: Week 96

Secondary outcomes (3)

Prostate Specific Antigen (PSA) Response
Measured: Week 96
Median Time to PSA Response
Measured: Week 96
Reduction in Chromogranin A Serum Levels
Measured: Baseline, Week 96

Timeline

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

Jun 2011Jun 2013

First posted11 Mar 2011 (estimated)
Study startJun 2011
Primary completionJun 2013
Study completionJun 2013

Why it stopped: Poor enrolment

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.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by IpsenThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01313273
Sponsor's protocol ID: A-93-52030-738
Other IDs: 2010-019862-10
Acronym: POSEIDON
Status last verified: Nov 2019
First submitted: 10 Mar 2011
Last updated: 22 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels
ClinicalTrials.gov ID: NCT01313273
Acronym / sponsor ID: POSEIDON / A-93-52030-738
Conditions: Prostate Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor enrolment
Enrolment: 3 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 11 Mar 2011 (estimated)
Results: Posted 14 Aug 2015

Clinical summary

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

Detailed description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Other	Drug: Non steroidal anti androgens and LHRH-a
Arm B	Experimental	Drug: Lanreotide, non steroidal anti androgens and LHRH-a

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histologically proven diagnosis of prostate cancer
Evidence of PSA progression despite castrate levels of testosterone (<50 ng/dL) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (LHRH-a)
Patients with non-metastatic or stable metastatic disease
Chromogranin A elevation above normal range (confirmed by a second evaluation at least 1 week later) [cut off levels will be > 20 U/L for enzyme linked immunosorbent (ELISA) assay and > 100 ng/ml for immunoradiometric (IRMA) assay]

Key exclusion criteria (4 listed)

Patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel)
First line treatment with antiandrogen in monotherapy
Visceral metastasis
Previous or concomitant treatment with a somatostatin analogue

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
Lanreotide, non steroidal anti androgens and LHRH-aLanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months. Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression.	Drug	Arm B
Non steroidal anti androgens and LHRH-aNon steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression	Drug	Arm A

Primary outcome

Progression-free Survival
Time frame: Week 96

3 secondary outcomes

Prostate Specific Antigen (PSA) Response
Time frame: Week 96
Median Time to PSA Response
Time frame: Week 96
Reduction in Chromogranin A Serum Levels
Time frame: Baseline, Week 96

Results and safety

Results posted to the registry on 14 Aug 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
Arm A: Non-steroidal Anti Androgens + LHRH-a	2	0
Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a	1	0

Primary outcome: Progression-free Survival

Time frame: Week 96

Population analysed: Study early terminated due to poor enrollment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were reported from Baseline (visit 2) to visit 10 (week 96 - End of study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Non-steroidal Anti Androgens + LHRH-a	0 of 2 (0%)	0 of 2 (0%)	Not reported
Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a	0 of 1 (0%)	1 of 1 (100%)	Not reported

Limitations and caveats (from the sponsor): Study terminated due to poor enrollment

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Active, not recruitingObservational study
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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
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

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.

Ipsen Medical Director study director

Ipsen

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lanreotide, non steroidal anti androgens and LHRH-a and Non steroidal anti androgens and LHRH-a in people with Prostate Cancer, run by Ipsen at 1 site in Italy.

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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 14 Aug 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?

Progression-free Survival (time frame: Week 96). 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 NCT01313273.

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 22 Nov 2019.