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History of Changes for Study: NCT02200614
Efficacy and Safety Study of ODM-201 in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer (ARAMIS)
Latest version (submitted June 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 23, 2014 None (earliest Version on record)
2 August 5, 2014 Study Status and Contacts/Locations
3 September 23, 2014 Recruitment Status, Study Status and Contacts/Locations
4 February 13, 2015 Contacts/Locations, Sponsor/Collaborators, Study Identification and Study Status
5 May 13, 2015 Contacts/Locations, Arms and Interventions, Study Status, Study Identification, Study Description, Eligibility, Outcome Measures and Conditions
6 May 29, 2015 Contacts/Locations and Study Status
7 June 18, 2015 Contacts/Locations and Study Status
8 July 17, 2015 Contacts/Locations and Study Status
9 August 17, 2015 Contacts/Locations and Study Status
10 September 16, 2015 Contacts/Locations and Study Status
11 October 16, 2015 Study Status and Contacts/Locations
12 November 13, 2015 Contacts/Locations and Study Status
13 December 11, 2015 Contacts/Locations and Study Status
14 January 11, 2016 Contacts/Locations and Study Status
15 February 2, 2016 Contacts/Locations and Study Status
16 March 4, 2016 Contacts/Locations and Study Status
17 April 1, 2016 Contacts/Locations and Study Status
18 May 3, 2016 Contacts/Locations and Study Status
19 May 26, 2016 Contacts/Locations, Study Description and Study Status
20 June 27, 2016 Contacts/Locations and Study Status
21 July 25, 2016 Contacts/Locations and Study Status
22 August 18, 2016 Contacts/Locations, Outcome Measures, Study Description, Study Status, Eligibility, Arms and Interventions, Sponsor/Collaborators and Study Identification
23 September 13, 2016 Contacts/Locations and Study Status
24 October 13, 2016 Contacts/Locations and Study Status
25 November 14, 2016 Contacts/Locations, Study Status and Eligibility
26 December 14, 2016 Contacts/Locations and Study Status
27 January 13, 2017 Contacts/Locations and Study Status
28 February 10, 2017 Contacts/Locations and Study Status
29 March 9, 2017 Study Status and Contacts/Locations
30 April 5, 2017 Contacts/Locations, Study Status and Oversight
31 May 5, 2017 Contacts/Locations and Study Status
32 June 5, 2017 Contacts/Locations and Study Status
33 July 5, 2017 Contacts/Locations and Study Status
34 August 3, 2017 Contacts/Locations and Study Status
35 August 31, 2017 Contacts/Locations and Study Status
36 September 26, 2017 Contacts/Locations, Oversight and Study Status
37 October 26, 2017 Contacts/Locations and Study Status
38 November 27, 2017 Contacts/Locations and Study Status
39 December 27, 2017 Study Status
40 January 25, 2018 Contacts/Locations and Study Status
41 February 26, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
42 March 29, 2018 Arms and Interventions, Study Status, Study Identification and Study Design
43 April 27, 2018 Contacts/Locations and Study Status
44 May 28, 2018 Study Status
45 June 27, 2018 Study Status
46 July 27, 2018 Contacts/Locations and Study Status
47 August 24, 2018 Contacts/Locations and Study Status
48 September 10, 2018 Contacts/Locations, Study Status and Study Design
49 November 28, 2018 Contacts/Locations, Study Status and Study Design
50 December 11, 2018 Study Status and Contacts/Locations
51 January 3, 2019 Contacts/Locations and Study Status
52 February 21, 2019 Contacts/Locations and Study Status
53 March 27, 2019 Study Status
54 May 23, 2019 Contacts/Locations and Study Status
55 June 20, 2019 Study Status
Show
Results Submission Events
56 October 9, 2019 Study Status, Outcome Measures, Document Section, Results, Contacts/Locations, Eligibility and Arms and Interventions
57 November 8, 2019 Study Status and Outcome Measures
58 December 9, 2019 Study Status and Contacts/Locations
59 January 7, 2020 Study Status
60 February 6, 2020 Arms and Interventions and Study Status
61 March 5, 2020 Study Status and Contacts/Locations
62 April 3, 2020 Document Section, Study Status and Contacts/Locations
63 May 7, 2020 Contacts/Locations and Study Status
64 June 9, 2020 Study Status and Contacts/Locations
65 July 9, 2020 Contacts/Locations and Study Status
66 August 17, 2020 Contacts/Locations and Study Status
67 September 29, 2020 Adverse Events, Participant Flow, Outcome Measures, Study Status, Baseline Characteristics and Contacts/Locations
68 November 10, 2020 Study Status and Contacts/Locations
69 December 10, 2020 Study Status
70 January 7, 2021 Contacts/Locations and Study Status
71 February 8, 2021 Study Status
72 March 10, 2021 Study Status and Contacts/Locations
73 April 12, 2021 Contacts/Locations and Study Status
74 May 12, 2021 Study Status and Contacts/Locations
75 June 21, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
76 July 15, 2021 Study Status, Study Design and Study Identification
77 June 2, 2022 Adverse Events, Participant Flow, Document Section, Outcome Measures, Contacts/Locations, Study Status, Baseline Characteristics and References
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Study NCT02200614
Submitted Date:  July 23, 2014 (v1)
Open or close this module Study Identification
Unique Protocol ID: 3104007
Brief Title: Efficacy and Safety Study of ODM-201 in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer (ARAMIS)
Official Title: A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of ODM-201 in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Not yet recruiting
Study Start: July 2014
Primary Completion: March 2018 [Anticipated]
Study Completion: December 2020 [Anticipated]
First Submitted: July 22, 2014
First Submitted that
Met QC Criteria:		 July 23, 2014
First Posted: July 25, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:		 July 23, 2014
Last Update Posted: July 25, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Orion Corporation, Orion Pharma
Responsible Party: Sponsor
Collaborators: Bayer
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to assess the safety and efficacy of ODM-201 in patients with non-metastatic castration-resistant prostate cancer.
Detailed Description:
Open or close this module Conditions
Conditions: Prostate Cancer Non-Metastatic Castration-Resistant
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ODM-201
ODM-201 tablets 2 x 300mg bid
 Drug: ODM-201
Placebo Comparator: Placebo
Matching placebo tablets x 2 bid
 Drug: Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Metastasis-Free Survival
[ Time Frame: Up to 72 months ]

Time from randomisation to evidence of metastasis or death from any cause, whichever occurs first
Secondary Outcome Measures:
1. Overall Survival
[ Time Frame: Up to 72 months ]

Date of death and primary cause of death will be recorded.
2. Time to first symptomatic skeletal event (SSE)
[ Time Frame: Up to 72 months ]

Date of first SSE will be recorded
3. Time to initiation of first cytotoxic chemotherapy
[ Time Frame: Up to 72 months ]

Name and start date of cytotoxic chemotherapy treatment will be recorded
4. Time to pain progression
[ Time Frame: Up to 72 months ]

Pain will be assessed by Brief Pain Inventory.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
  • Progressive Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
  • Prostate-specific antigen doubling time of ≤ 10 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl (1.5x109/l), platelet count ≥ 100,000/µl (100x109/l ).
  • Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
  • Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the study treatment.

Exclusion Criteria:

  • History of metastatic disease or presence of detectable metastases.
  • Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
  • Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, OR CYP17 enzyme inhibitor.
  • Use of estrogens, 5-α reductase inhibitors or AR inhibitors.
  • Prior chemotherapy or immunotherapy for prostate cancer.
  • Use of systemic corticosteroid.
  • Radiation therapy within 12 weeks before randomisation.
  • Severe or uncontrolled concurrent disease, infection or co-morbidity.
  • Initiation of treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
  • Known hypersensitivity to the study treatment or any of its ingredients.
  • Major surgery within 28 days before randomisation.
  • Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
  • Uncontrolled hypertension.
  • Prior malignancy.
  • Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
  • Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
  • Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
Open or close this module Contacts/Locations
Central Contact Person: Andrew Wighton
Telephone: +44 (0)115 9487 124
Email: andrew.wighton@orionpharma.com
Study Officials: Karim Fizazi
Principal Investigator
Institut Gustave Roissy
Locations: United States, Colorado
Denver, Colorado, United States
United States, Idaho
Coeur D'Alene, Idaho, United States
United States, Ohio
Canton, Ohio, United States
United States, South Carolina
Myrtle Beach, South Carolina, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services