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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01360840




Registration number
NCT01360840
Ethics application status
Date submitted
15/04/2011
Date registered
26/05/2011
Date last updated
14/12/2015

Titles & IDs
Public title
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Secondary ID [1] 0 0
EMR 62242-006
Universal Trial Number (UTN)
Trial acronym
PERSEUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Metastatic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EMD 525797
Treatment: Drugs - EMD 525797
Other interventions - Placebo
Other interventions - Standard of Care (SoC)

Placebo Comparator: Placebo + Standard of care (SoC) -

Experimental: EMD 525797 750 mg + SoC -

Experimental: EMD 525797 1500 mg + SoC -


Treatment: Drugs: EMD 525797
Subjects will be administered with EMD 525797 at a dose of 1500 milligram (mg) (diluted with 0.9 percent [%] sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.

Treatment: Drugs: EMD 525797
Subjects will be administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.

Other interventions: Placebo
Subjects will be administered with placebo (as 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.

Other interventions: Standard of Care (SoC)
All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Time - PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Timepoint [1] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [1] 0 0
Overall Survival - Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Timepoint [1] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [2] 0 0
Time to Tumor Progression - Time to tumor progression was defined as the time from the date of randomization to the date of ORDP. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which had to be confirmed by bone scintigraphy 6 weeks later if subjects remained asymptomatic or mildly symptomatic. Assessments were to be based on RECIST v1.0 modified according to PCWG-2; Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Timepoint [2] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [3] 0 0
Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions - Presence of tumor response in soft tissue lesions was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) in soft tissue lesions, documented by computed tomography (CT) scans. Presence of DC in soft tissue lesions was defined as the presence of at least 1 confirmed CR or confirmed PR or stable disease (SD) lasting at least 12 weeks after randomization. Tumor response assessments were based on RECIST v1.0 modified according to the PCWG-2. The response was evaluated for subjects with measurable disease at baseline. According to RECIST v1.0, CR=disappearance of all target and non-target lesions; PR=at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions.
Timepoint [3] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [4] 0 0
Number of Subjects With New Bone Lesions Compared to Baseline - New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.
Timepoint [4] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [5] 0 0
Number of Subjects With Presence of DC in Bone Lesions - Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.
Timepoint [5] 0 0
At Weeks 13, 19 and 25
Secondary outcome [6] 0 0
Bone and Soft Tissue Lesions Composite Tumor Response - Bone and soft tissue lesions composite tumor response was defined as the presence of both a confirmed CR or PR, documented by CT scans, and a DC in bone lesions, documented by bone scintigraphy. CR was defined as disappearance of all target and non-target lesions and PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions. Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions.
Timepoint [6] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [7] 0 0
Number of Subjects With Presence of Skeletal Related Events - Presence of skeletal related events was defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms at the investigator discretion. Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Timepoint [7] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [8] 0 0
Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response - PSA response was defined as a decrease greater than 50 percent (%) in PSA value from baseline for 2 consecutive evaluations greater than or equal to (>=) 3 Weeks apart.
Timepoint [8] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [9] 0 0
Minimum Percentage Change From Baseline in PSA Serum Concentration
Timepoint [9] 0 0
Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [10] 0 0
Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)
Timepoint [10] 0 0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [11] 0 0
Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)
Timepoint [11] 0 0
Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose
Secondary outcome [12] 0 0
Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation - An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 50 days after last dose.
Timepoint [12] 0 0
From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years
Secondary outcome [13] 0 0
Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss) - The apparent total body clearance of drug following intravenous administration (CL); The apparent total body clearance of drug at steady state following intravenous administration (CLss).
Timepoint [13] 0 0
Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI
Secondary outcome [14] 0 0
Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion - The apparent volume of distribution during the terminal phase following intravenous administration (V). The estimate of the apparent volume of distribution at steady state following intravenous administration (Vss).
Timepoint [14] 0 0
Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason
score)

- Bisphosphonate treatment

- Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of
testosterone (less than or equal to) <= 50 nanogram per deciliter [ng/dL]) for
subjects without surgical castration (luteinizing hormone-releasing hormone
antagonists and agonists)

- Other protocol defined inclusion criteria could apply
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy
for mCRPC

- Chronic and ongoing treatment with opioids

- Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening

- Visceral metastasis, brain metastasis

- Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any
kinds of major elective surgery within 30 days prior to trial treatment

- Other protocol defined exclusion criteria could apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bendigo
Recruitment hospital [2] 0 0
Research Site - Coffs Harbour
Recruitment hospital [3] 0 0
Research Site - Darlinghurst
Recruitment hospital [4] 0 0
Research Site - Frankston
Recruitment hospital [5] 0 0
Research Site - Gosford
Recruitment hospital [6] 0 0
Research Site - Kurralta Park
Recruitment hospital [7] 0 0
Research Site - Northmead
Recruitment hospital [8] 0 0
Research Site - Port Macquarie
Recruitment hospital [9] 0 0
Research Site - Randwick
Recruitment hospital [10] 0 0
Research Site - Turnhout
Recruitment postcode(s) [1] 0 0
- Bendigo
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- Frankston
Recruitment postcode(s) [5] 0 0
- Gosford
Recruitment postcode(s) [6] 0 0
- Kurralta Park
Recruitment postcode(s) [7] 0 0
- Northmead
Recruitment postcode(s) [8] 0 0
- Port Macquarie
Recruitment postcode(s) [9] 0 0
- Randwick
Recruitment postcode(s) [10] 0 0
- Turnhout
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerp
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Abbotsford
Country [13] 0 0
Canada
State/province [13] 0 0
Province of British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Toronto
Country [15] 0 0
Canada
State/province [15] 0 0
Victoria
Country [16] 0 0
Canada
State/province [16] 0 0
Windsor
Country [17] 0 0
France
State/province [17] 0 0
Angers
Country [18] 0 0
France
State/province [18] 0 0
Bourgogne
Country [19] 0 0
France
State/province [19] 0 0
Caen Cedex 05
Country [20] 0 0
France
State/province [20] 0 0
Colmar
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Reims
Country [23] 0 0
France
State/province [23] 0 0
Villejuif
Country [24] 0 0
Germany
State/province [24] 0 0
Aachen
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Darmstadt
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Esslingen
Country [29] 0 0
Germany
State/province [29] 0 0
Freiburg
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Nürtingen
Country [32] 0 0
Germany
State/province [32] 0 0
Reutlingen
Country [33] 0 0
Germany
State/province [33] 0 0
Tübingen
Country [34] 0 0
Netherlands
State/province [34] 0 0
Blaricum
Country [35] 0 0
Netherlands
State/province [35] 0 0
Groningen
Country [36] 0 0
Netherlands
State/province [36] 0 0
Haarlem
Country [37] 0 0
Poland
State/province [37] 0 0
Gdansk
Country [38] 0 0
Poland
State/province [38] 0 0
Lublin
Country [39] 0 0
Poland
State/province [39] 0 0
Lódz
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Barnaul
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Ekaterinburg
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Ivanovo
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Izhevsk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Kazan
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Krasnoyarsk
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Omsk
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Petersburg
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Stavropol
Country [49] 0 0
Slovakia
State/province [49] 0 0
Presov
Country [50] 0 0
South Africa
State/province [50] 0 0
Gauteng
Country [51] 0 0
South Africa
State/province [51] 0 0
Kwa-Zulu Natal
Country [52] 0 0
South Africa
State/province [52] 0 0
Pretoria Gauteng
Country [53] 0 0
South Africa
State/province [53] 0 0
Western Cape
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelone
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Pamplona
Country [57] 0 0
Spain
State/province [57] 0 0
Sabadell, Barcelone

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD
525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free
survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic
castrate-resistant prostate cancer (mCRPC).
Trial website
https://clinicaltrials.gov/show/NCT01360840
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications