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

• Sponsor: Ipsen (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01313273
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Lanreotide, non steroidal anti androgens and LHRH-a; Drug: Non steroidal anti androgens and LHRH-a	Phase 3

Detailed Description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm A	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
Experimental: Arm B	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.

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival [Week 96]

Secondary Outcome Measures

1. Prostate Specific Antigen (PSA) Response [Week 96]

2. Median Time to PSA Response [Week 96]

3. Reduction in Chromogranin A Serum Levels [Baseline, Week 96]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	A.O. S. Luigi Gonzaga	Orbassano ( TO)		Italy

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT01313273
• Other Study ID Numbers: A-93-52030-738; 2010-019862-10
• First Posted: Mar 11, 2011
• Last Update Posted: Nov 22, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Prostatic Neoplasms; Ascorbic Acid; Methyltestosterone; Lanreotide; Androgens; Estrogens, Conjugated (USP); Prolactin Release-Inhibiting Factors; Androgen Antagonists; Nonsteroidal Anti-Androgens

Study Results

Participant Flow

Recruitment Details	Subjects ≥18 years meeting inclusion criteria were recruited for this study.
Pre-assignment Detail	Investigators screened 8 subjects. Randomised 3 subjects and 5 were not randomised.

Arm/Group Title	Arm A: Non-steroidal Anti Androgens + LHRH-a	Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a
Arm/Group Description	Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.	Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
Period Title: Overall Study
STARTED	2	1
COMPLETED	0	0
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Arm A: Non-steroidal Anti Androgens + LHRH-a	Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a	Total
Arm/Group Description	Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.	Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.	Total of all reporting groups
Overall Participants	2	1	3
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	72.50	57.00	61.00
Age, Customized (Number) [Number]
>=65 years	1 50%	0 0%	1 33.3%
Between 18 and 65 years	1 50%	1 100%	2 66.7%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	2 100%	1 100%	3 100%
Region of Enrollment (participants) [Number]
Italy	2 100%	1 100%	3 100%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Study early terminated due to poor enrollment.

Arm/Group Title	Arm A: Non-steroidal Anti Androgens + LHRH-a	Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group Description	Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.	Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
Measure Participants	0	0

2. Secondary Outcome

Title	Prostate Specific Antigen (PSA) Response
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Study early terminated due to poor enrollment

Arm/Group Title	Arm A: Non-steroidal Anti Androgens + LHRH-a	Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group Description	Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.	Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
Measure Participants	0	0

3. Secondary Outcome

Title	Median Time to PSA Response
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Study early terminated due to poor enrollment

Arm/Group Title	Arm A: Non-steroidal Anti Androgens + LHRH-a	Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group Description	Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.	Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
Measure Participants	0	0

4. Secondary Outcome

Title	Reduction in Chromogranin A Serum Levels
Time Frame	Baseline, Week 96

Outcome Measure Data

Analysis Population Description

Study early terminated due to poor enrollment

Arm/Group Title	Arm A: Non-steroidal Anti Androgens + LHRH-a	Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group Description	Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.	Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
Measure Participants	0	0

Adverse Events

Time Frame	AEs were reported from Baseline (visit 2) to visit 10 (week 96 - End of study)
Adverse Event Reporting Description	All Adverse Events (AEs) documented for this study were treatment emergent. Overall, for 1 patient (100.0%) of Arm B at least one AE, at least one AE related to study treatment and at least one severe AE were reported.
Arm/Group Title	Arm A: Non-steroidal Anti Androgens + LHRH-a		Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
Arm/Group Description	Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.		Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
All Cause Mortality
	Arm A: Non-steroidal Anti Androgens + LHRH-a		Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A: Non-steroidal Anti Androgens + LHRH-a		Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Arm A: Non-steroidal Anti Androgens + LHRH-a		Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		1/1 (100%)
Gastrointestinal disorders
Diarrhoea	0/2 (0%)	0	1/1 (100%)	3
Investigations
Transaminases increased	0/2 (0%)	0	1/1 (100%)	1

Limitations/Caveats

Study terminated due to poor enrollment

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.