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ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.

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ClinicalTrials.gov Identifier: NCT02933801
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:
The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Prostate Cancer Drug: ODM-201 Other: Placebo Phase 2

Detailed Description:

The treatment of metastatic castration-resistant prostate cancer has evolved rapidly over the past few years. First line treatment with one of the novel antihormonal drugs abiraterone or enzalutamide followed by chemotherapy with docetaxel is now standard of care. If a patient has disease stabilization on chemotherapy he undergoes a watchful waiting period and further treatment is only started at the time of disease progression. This trial tests the immediate use of the novel androgen receptor antagonist ODM-201 as maintenance treatment after chemotherapy aiming at prolonging radiographic progression free survival as compared to watchful waiting.

The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ODM-201 Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Non-progressive Disease After Subsequent Treatment With a Taxane: A Multicenter Randomized Double-blind Placebo-controlled Phase II Trial.
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm A: ODM-201
600mg ODM-201 BID (twice daily) and Best Supportive Care until progression
Drug: ODM-201
ODM-201 will be given at a dose of 600 mg BID orally on a continuous basis.
Other Name: BAY-1841788

Placebo Comparator: Arm B: Placebo
Placebo BID (twice daily) and Best Supportive Care until progression
Other: Placebo
Placebo will be given at a dose of 600 mg BID orally on a continuous basis.




Primary Outcome Measures :
  1. Radiographic progression-free survival (rPFS) at 12 weeks [ Time Frame: At 12 weeks after treatment start ]
    Radiographic progression-free survival is defined as the time from treatment start to radiographic disease progression or death from any cause, whichever occurs earlier.


Secondary Outcome Measures :
  1. Radiographic progression-free survival (rPFS) [ Time Frame: Every 12 weeks until disease progression (estimated up to 1 year) ]
    Radiographic progression-free survival is defined as the time from treatment start to radiographic disease progression or death from any cause, whichever occurs earlier.

  2. Time to PSA progression [ Time Frame: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year) ]

    PSA progression is defined as:

    • In case PSA levels had not decreased under treatment with the study drug: ≥ 25% increase over baseline (last PSA measurement before treatment start) AND an increase in the absolute PSA value of ≥ 5 ng/mL.
    • In case of PSA response < 50% under treatment with the study drug: ≥ 25% increase over the nadir AND an increase in the absolute PSA value of ≥ 5 ng/mL.
    • In case of PSA response ≥ 50% under treatment with the study drug: ≥ 50% increase over the nadir AND an increase in the absolute PSA value of ≥ 5 ng/mL

  3. Time to symptomatic/clinical progression [ Time Frame: treatment start to the time point of symptomatic/clinical progression (estimated up to 1 year) ]

    Symptomatic/clinical progression is defined by one of the following:

    • Occurrence of a SRE due to bone metastases, defined as pathologic fracture, spinal cord compression, palliative radiation to bone, or surgery to bone
    • Treating physician decides for intervention due to new disease related complications (e.g., urinary obstruction, hydronephrosis)

  4. Event-free survival [ Time Frame: treatment start until the event of interest (estimated up to 1 year) ]
    Event-free survival is defined as the time from treatment start until the event of interest.

  5. Overall survival [ Time Frame: time from trial randomization to the date of death from any cause (estimated up to 6 years) ]
    Overall survival is defined as the time from treatment start until death from any cause.

  6. PSA response (30%, 50%, 90% and best) [ Time Frame: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year) ]

    30% PSA response is defined as a decrease in PSA level of at least 30% (compared to baseline PSA).

    50% PSA response is defined as a decrease in PSA level of at least 50% (compared to baseline PSA).

    90% PSA response is defined as a decrease in PSA level of at least 90% (compared to baseline PSA).

    Best PSA response is defined as the percentage of change in PSA from baseline to the maximum decline in PSA at any point under treatment. If there is a steady increase after baseline, the best response is defined as the percentage of change in PSA from baseline to the minimum increase in PSA at any point under treatment. Baseline is defined as the latest recorded measurement prior to the first dose of trial treatment.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures not part of normal medical care.
  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
  • Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
  • Metastatic disease, documented by imaging
  • Total testosterone ≤ 50 ng/dL (≤ 1.7 nmol/L)
  • Treatment with abiraterone AND/OR enzalutamide for at least 8 weeks prior to taxane based chemotherapy
  • No evidence of disease progression after chemotherapy with docetaxel (at least cumulative dose of ≥ 300 mg/m2 or total dose ≥ 600mg) or cabazitaxel (at least cumulative dose of ≥ 80 mg/m2 or total dose ≥ 160 mg)

    • No evidence of progression on imaging according to PCWG3
    • No evidence of progression on PSA levels referred to the nadir since start of taxane treatment (PSA progression defined as > 25% increase of PSA level or >50% if PSA decrease under chemotherapy >50% AND > 5 ng/mL increase in the absolute PSA value)
  • Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
  • Planned start of trial treatment 2 to 8 weeks after last taxane dose
  • Male patient 18 years or older
  • WHO performance status of ≤2
  • Laboratory values as specified below

    • alanine aminotransferase (ALT) ≤ 2.5 x ULN (except for patients with liver metastases ≤ 5.0 x ULN)
    • Total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN)
    • Estimated creatinine clearance using the Cockcroft-Gault formula > 30 mL/minute
    • Blood counts at screening: haemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1500/μl (1.5x109/L), platelet count ≥ 100,000/μl (100x109/L) (patient must not have received any growth factor or blood transfusion within 7 days of the haematology laboratory obtained at screening)
  • Adequate cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 40% as determined by echocardiography (ECHO)
  • Patient is able and willing to swallow trial drug as whole tablet
  • Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the study treatment and for 3 months after the end of the treatment.
  • Patient agrees to participate in the mandatory translational research project

Exclusion Criteria:

  • Prior chemotherapy for prostate cancer except from chemotherapy with a taxane
  • Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
  • Known CNS or leptomeningeal metastases
  • Clinical or radiological evidence of current spinal cord compression
  • History of hematologic or primary solid tumor malignancy, unless in remission for at least 2 years from registration with the exception of localized non-melanoma skin cancer or carcinoma in situ having undergone complete resection.
  • Prior therapy for mCRPC with modern anti-hormonal treatment except for enzalutamide or abiraterone
  • Concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry (except clinical trial SAKK 96/12)
  • Concomitant use of other anti-cancer drugs or radiotherapy except for local pain control and GnRH analogues
  • Severe or uncontrolled cardiovascular disease
  • Acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before expected start of treatment
  • ECG abnormalities of Q-wave infarction, unless identified ≥ 6 months prior to registration or QTc interval >480 msec
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of ODM-201
  • Known hypersensitivity to trial drug or to any component of the trial drug
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933801


Contacts
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Contact: Eloïse Kremer, PhD +41 31 389 91 91 trials@sakk.ch

Locations
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Italy
European Institute of Oncology (EIO) Recruiting
Milano, Italy, 20141
Contact: Franco Nole, MD    Phone: +39 (0)2 574 89 502    franco.nole@ieo.it   
Principal Investigator: Franco Nole, MD         
Istituto Nazionale dei Tumori - IRCCS Fondazione Recruiting
Milano, Italy, 20141
Contact: Giuseppe Procopio, MD    +39 (0)2 239 02 557    giuseppe.procopio@istitutotumori.mi.it   
Principal Investigator: Giuseppe Procopio, MD         
Istituto Nazionale dei Tumori - IRCCS Fondazione Pascale S.C. Recruiting
Napoli, Italy, 80131
Contact: Gaetano Facchini, MD    +39 (0)2 239 04 450    g.facchini@istitutotumori.na.it   
Principal Investigator: Gaetano Facchini, MD         
AOU "Maggiore della Carità" di S.C. di Oncologia Recruiting
Novara, Italy, 28100
Contact: Alessandra Mosca, MD    +39 (0)3 213 73 2115    alessandramosca25@yahoo.it   
Principal Investigator: Alessandra Mosca, MD         
AOU San Luigi Gonzaga Recruiting
Orbassano, Italy, 10043
Contact: Giorgio Vittorio Scagliotti, Prof    +39 (0)1 190 26 979    giorgio.scagliotti@unito.it   
Principal Investigator: Giorgio Vittorio Scagliotti, Prof         
AO San Camillo and Forlanini Hospitals Recruiting
Roma, Italy, 00152
Contact: Cora N. Sternberg, MD    +39 (0)6 663 0771    cstern@mclink.it   
Principal Investigator: Cora N. Sternberg, MD         
Presidio Ospedaliero Santa Chiara Recruiting
Trento, Italy, 38122
Contact: Orazio Caffo, MD    +39 (0)4 61 902 121    orazio.caffo@apss.tn.it   
Principal Investigator: Orazio Caffo, MD         
Azienda Ospedaliera Universitaria Integrate Verona (AOUI) Recruiting
Verona, Italy, 37126
Contact: Gianpaolo Tortora, Prof    +39 045 812 11 11    giampaolo.tortora@univr.it   
Principal Investigator: Gianpaolo Tortora, Prof         
Spain
Hospital de Torrecárdenas Recruiting
Almería, Spain, 04009
Contact: Ana Fernandez-Freire Leal, MD    +34 950 01 60 00    anafdezfreire@hotmail.com   
Principal Investigator: Ana Fernandez-Freire Leal, MD         
Hospital Universitario Infanta Cristina Recruiting
Badajoz, Spain, 06080
Contact: Juan Ignacio Delgado Mingorance, MD    +34 924 21 81 00    ignadelgado@hotmail.com   
Principal Investigator: Juan Ignacio Delgado Mingorance, MD         
Hospital Clinic Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Begona Mellado Gonzalez, MD    +34 932 27 54 00    bmellado@clinic.ub.es   
Principal Investigator: Begona Mellado Gonzalez, MD         
Consorcio Hospitalario Provincial de Castellon Recruiting
Castellón De La Plana, Spain, 12002
Contact: Alfredo Sanchez, MD    +34 964 354 355    asanchezh@seom.org   
Principal Investigator: Alfredo Sanchez, MD         
Hospital Universitario San Cecilio Recruiting
Granada, Spain, 18016
Contact: José Miguel Jurado, MD    +34 6100 13426    jmjurado88@gmail.com   
Principal Investigator: José Miguel Jurado, MD         
Hospital Univ. de Guadalajara Recruiting
Guadalajara, Spain, 19002
Contact: Javier Cassinello Espinosa, MD    +34 609 150 666    jacaes@sescam.jccm.es   
Principal Investigator: Javier Cassinello Espinosa         
Centro Integral Oncológico Clara Campal - Hospital Universitario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Juan Francisco Rodriguez Moreno, MD    +34 902 08 98 00    jfrodriguez@hmhospitales.com   
Principal Investigator: Juan Francisco Rodriguez Moreno, MD         
Hospital Universitario Puerta de Hierro-Majadahonda Recruiting
Majadahonda, Spain, 28222
Contact: Aranzazu Gonzalez del Alba, MD    +34 619 196 989    aranglezalba@yahoo.es   
Principal Investigator: Aranzazu Gonzalez del Alba, MD         
Hospital General Universitario Morales Meseguer Recruiting
Murcia, Spain, 30008
Contact: Enrique Gonzalez Billalabeitia, MD    +34 968 36 09 00    enrique.gonzalezbilla@gmail.com   
Principal Investigator: Enrique Gonzalez Billalabeitia, MD         
Complejo Hospital Universitario de Santiago de Compostela Recruiting
Santiago De Compostela, Spain, 15706
Contact: Urbano Anido Herranz, MD    34 981 95 00 00    urbanoanido@gmail.com   
Principal Investigator: Urbano Anido Herranz, MD         
Switzerland
Kantonsspital Baden Recruiting
Baden, Switzerland, CH-5404
Contact: Andreas Erdmann, MD    +41 56 486 27 62    andreas.erdmann@ksb.ch   
Principal Investigator: Andreas Erdmann, MD         
Istituto Oncologico della Svizzera Italiana (IOSI) Recruiting
Bellinzona, Switzerland, 6500
Contact: Ricardo Pereira Mestre, MD    +41 91 811 84 46    ricardo.pereiramestre@eoc.ch   
Principal Investigator: Ricardo Pereira Mestre, MD         
Kantonsspital Graubuenden Recruiting
Chur, Switzerland, 7000
Contact: Richard Cathomas, MD    +41 81 256 66 95    richard.cathomas@ksgr.ch   
Principal Investigator: Richard Cathomas, MD         
Hôpital Fribourg HFR Recruiting
Fribourg, Switzerland, 1708
Contact: Marc Küng, MD    +41 26 426 72 43    marc.kueng@h-fr.ch   
Principal Investigator: Marc Küng, MD         
Kantonsspital Liestal Recruiting
Liestal, Switzerland, CH-4410
Contact: Bettina Seifert, MD    +41 61 925 34 03    bettina.seifert@ksli.ch   
Principal Investigator: Bettina Seifert, MD         
Fondazione Oncologia / Oncologia ematologia Recruiting
Locarno, Switzerland, 6600
Contact: Augusto Pedrazzini, MD    +41 91 752 3535    a.pedrazzini@oncologia-pedrazzini.ch   
Principal Investigator: Augusto Pedrazzini, MD         
Kantonsspital Muensterlingen Recruiting
Münsterlingen, Switzerland, 8596
Contact: Roman Inauen, MD    +41 71 686 11 11    roman.inauen@stgag.ch   
Principal Investigator: Roman Inauen, MD         
Hôpital du Valais (Sion et Martigny) Recruiting
Sion, Switzerland, 1951
Contact: Sandro Anchisi, MD    +41 27 603 45 00    sandro.anchisi@hopitalvs.ch   
Principal Investigator: Sandro Anchisi, MD         
Kantonsspital - St. Gallen Recruiting
St. Gallen, Switzerland, CH-9007
Contact: Aurelius Omlin, MD    +41 71 494 29 22    aurelius.omlin@kssg.ch   
Principal Investigator: Aurelius Omlin, MD         
Spital STS AG Recruiting
Thun, Switzerland, CH-3600
Contact: Daniel Rauch, MD    +41 33 226 26 45    daniel.rauch@spitalstsag.ch   
Principal Investigator: Daniel Rauch, MD         
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Silke Gillessen, Prof Cantonal Hospital of St. Gallen

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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT02933801     History of Changes
Other Study ID Numbers: SAKK 08/16
2016-003996-23 ( EudraCT Number )
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swiss Group for Clinical Cancer Research:
metastatic castration resistant prostate cancer (mCRPC)
Prostate Cancer
phase II trial
ODM-201
maintenance therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases