Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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)
Query!
Secondary ID [1]
0
0
EMR 62242-006
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PERSEUS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer Metastatic
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
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).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS) Time
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [1]
0
0
Overall Survival
Query!
Assessment method [1]
0
0
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Query!
Timepoint [1]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [2]
0
0
Time to Tumor Progression
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [3]
0
0
Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [4]
0
0
Number of Subjects With New Bone Lesions Compared to Baseline
Query!
Assessment method [4]
0
0
New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.
Query!
Timepoint [4]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [5]
0
0
Number of Subjects With Presence of DC in Bone Lesions
Query!
Assessment method [5]
0
0
Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.
Query!
Timepoint [5]
0
0
At Weeks 13, 19 and 25
Query!
Secondary outcome [6]
0
0
Bone and Soft Tissue Lesions Composite Tumor Response
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [7]
0
0
Number of Subjects With Presence of Skeletal Related Events
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [8]
0
0
Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [9]
0
0
Minimum Percentage Change From Baseline in PSA Serum Concentration
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [10]
0
0
Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Query!
Secondary outcome [11]
0
0
Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)
Query!
Assessment method [11]
0
0
Query!
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
Query!
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
Query!
Assessment method [12]
0
0
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.
Query!
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
Query!
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)
Query!
Assessment method [13]
0
0
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).
Query!
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
Query!
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
Query!
Assessment method [14]
0
0
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).
Query!
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
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
180
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Bendigo
Query!
Recruitment hospital [2]
0
0
Research Site - Coffs Harbour
Query!
Recruitment hospital [3]
0
0
Research Site - Darlinghurst
Query!
Recruitment hospital [4]
0
0
Research Site - Frankston
Query!
Recruitment hospital [5]
0
0
Research Site - Gosford
Query!
Recruitment hospital [6]
0
0
Research Site - Kurralta Park
Query!
Recruitment hospital [7]
0
0
Research Site - Northmead
Query!
Recruitment hospital [8]
0
0
Research Site - Port Macquarie
Query!
Recruitment hospital [9]
0
0
Research Site - Randwick
Query!
Recruitment hospital [10]
0
0
Research Site - Turnhout
Query!
Recruitment postcode(s) [1]
0
0
- Bendigo
Query!
Recruitment postcode(s) [2]
0
0
- Coffs Harbour
Query!
Recruitment postcode(s) [3]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [4]
0
0
- Frankston
Query!
Recruitment postcode(s) [5]
0
0
- Gosford
Query!
Recruitment postcode(s) [6]
0
0
- Kurralta Park
Query!
Recruitment postcode(s) [7]
0
0
- Northmead
Query!
Recruitment postcode(s) [8]
0
0
- Port Macquarie
Query!
Recruitment postcode(s) [9]
0
0
- Randwick
Query!
Recruitment postcode(s) [10]
0
0
- Turnhout
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Illinois
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Louisiana
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Michigan
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Ohio
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Virginia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Washington
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Antwerp
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Ontario
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Abbotsford
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Province of British Columbia
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Toronto
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Victoria
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Windsor
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Angers
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Bourgogne
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Caen Cedex 05
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Colmar
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Paris
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Reims
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Villejuif
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Aachen
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Berlin
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Darmstadt
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Dresden
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Esslingen
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Freiburg
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Hannover
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Nürtingen
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Reutlingen
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Tübingen
Query!
Country [34]
0
0
Netherlands
Query!
State/province [34]
0
0
Blaricum
Query!
Country [35]
0
0
Netherlands
Query!
State/province [35]
0
0
Groningen
Query!
Country [36]
0
0
Netherlands
Query!
State/province [36]
0
0
Haarlem
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Gdansk
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Lublin
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Lódz
Query!
Country [40]
0
0
Russian Federation
Query!
State/province [40]
0
0
Barnaul
Query!
Country [41]
0
0
Russian Federation
Query!
State/province [41]
0
0
Ekaterinburg
Query!
Country [42]
0
0
Russian Federation
Query!
State/province [42]
0
0
Ivanovo
Query!
Country [43]
0
0
Russian Federation
Query!
State/province [43]
0
0
Izhevsk
Query!
Country [44]
0
0
Russian Federation
Query!
State/province [44]
0
0
Kazan
Query!
Country [45]
0
0
Russian Federation
Query!
State/province [45]
0
0
Krasnoyarsk
Query!
Country [46]
0
0
Russian Federation
Query!
State/province [46]
0
0
Omsk
Query!
Country [47]
0
0
Russian Federation
Query!
State/province [47]
0
0
Petersburg
Query!
Country [48]
0
0
Russian Federation
Query!
State/province [48]
0
0
Stavropol
Query!
Country [49]
0
0
Slovakia
Query!
State/province [49]
0
0
Presov
Query!
Country [50]
0
0
South Africa
Query!
State/province [50]
0
0
Gauteng
Query!
Country [51]
0
0
South Africa
Query!
State/province [51]
0
0
Kwa-Zulu Natal
Query!
Country [52]
0
0
South Africa
Query!
State/province [52]
0
0
Pretoria Gauteng
Query!
Country [53]
0
0
South Africa
Query!
State/province [53]
0
0
Western Cape
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Barcelone
Query!
Country [55]
0
0
Spain
Query!
State/province [55]
0
0
Madrid
Query!
Country [56]
0
0
Spain
Query!
State/province [56]
0
0
Pamplona
Query!
Country [57]
0
0
Spain
Query!
State/province [57]
0
0
Sabadell, Barcelone
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
EMD Serono
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT01360840
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Responsible
Query!
Address
0
0
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01360840
Download to PDF