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NCT01313273·Phase 3·INTERVENTIONAL

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

LanreotideOtherTerminated

Status

Terminated

Phase

Phase 3

Enrollment

3

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Interventions

Treatment arms and agents.

DRUG

Lanreotide, non steroidal anti androgens and LHRH-a

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.

DRUG

Non steroidal anti androgens and LHRH-a

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

Timeline

From registration to results.

  1. First posted

    Mar 11, 2011

  2. Study start

    Jun 2011

  3. Primary completion

    Jun 2013

  4. Study completion

    Jun 2013

  5. Results posted

    Aug 14, 2015

  6. Registry updated

    Nov 22, 2019

Outcomes

What the study measures.

Primary outcomes

Progression-free Survival

Time frame · Week 96

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

Inclusion Criteria: * 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) \[cut off levels will be \> 20 U/L for enzyme linked immunosorbent (ELISA) assay and \> 100 ng/ml for immunoradiometric (IRMA) assay\] Exclusion Criteria: * 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

Study locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

A.O. S. Luigi Gonzaga

Orbassano ( TO), Italy

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsLanreotide trial dashboard →DatabaseLanreotide database entry →ResearchLanreotide research guide →