ODM-201 Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With One Novel Hormonal Agent First Line and Non-progressive Disease After Second Line Treatment With a Taxane: A Multicenter Randomize

Condition: Prostate Cancer Metastatic, Prostate Cancer

Intervention:

• Drug: ODM-201
• Other: Placebo

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02933801

Sponsor: Swiss Group for Clinical Cancer Research

Primary Outcome Measures:

• Measure: Radiographic progression-free survival (rPFS) at 12 weeks
• Time Frame: At 12 weeks after treatment start
• Safety Issue:

Secondary Outcome Measures:

• Measure: Radiographic progression-free survival (rPFS)
• Time Frame: Every 12 weeks until disease progression (estimated up to 1 year)
• Safety Issue:
• Measure: Time to PSA progression
• Time Frame: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)
• Safety Issue:
• Measure: Time to symptomatic/clinical progression
• Time Frame: treatment start to the time point of symptomatic/clinical progression (estimated up to 1 year)
• Safety Issue:
• Measure: Event-free survival
• Time Frame: treatment start until the event of interest (estimated up to 1 year)
• Safety Issue:
• Measure: Overall survival
• Time Frame: time from trial randomization to the date of death from any cause (estimated up to 6 years)
• Safety Issue:
• Measure: 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)
• Safety Issue:

Estimated Enrollment: 88

Study Start Date: March 31, 2017

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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 (1.5×109/L), platelet count ≥ 100,000/μl (100×109/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.

Contact:

• Eloïse Kremer, PhD
• trials@sakk.ch
• +41 31 389 91 91

Locations:

• European Institute of Oncology (EIO)
• Milano 20141 Italy

• Istituto Nazionale dei Tumori – IRCCS Fondazione
• Milano 20141 Italy

• Istituto Nazionale dei Tumori – IRCCS Fondazione Pascale S.C.
• Napoli 80131 Italy

• AOU “Maggiore della Carità” di S.C. di Oncologia
• Novara 28100 Italy

• AOU San Luigi Gonzaga
• Orbassano 10043 Italy

• AO San Camillo and Forlanini Hospitals
• Roma 00152 Italy

• Presidio Ospedaliero Santa Chiara
• Trento 38122 Italy

• Azienda Ospedaliera Universitaria Integrate Verona (AOUI)
• Verona 37126 Italy

• Hospital de Torrecárdenas
• Almería 04009 Spain

• Hospital Universitario Infanta Cristina
• Badajoz 06080 Spain

• Hospital Clinic Barcelona
• Barcelona 08036 Spain

• Consorcio Hospitalario Provincial de Castellon
• Castellón De La Plana 12002 Spain

• Hospital Universitario San Cecilio
• Granada 18016 Spain

• Hospital Univ. de Guadalajara
• Guadalajara 19002 Spain

• Centro Integral Oncológico Clara Campal – Hospital Universitario HM Sanchinarro
• Madrid 28050 Spain

• Hospital Universitario Puerta de Hierro-Majadahonda
• Majadahonda 28222 Spain

• Hospital General Universitario Morales Meseguer
• Murcia 30008 Spain

• Complejo Hospital Universitario de Santiago de Compostela
• Santiago De Compostela 15706 Spain

• Kantonsspital Baden
• Baden CH-5404 Switzerland

• Istituto Oncologico della Svizzera Italiana (IOSI)
• Bellinzona 6500 Switzerland

• Kantonsspital Graubuenden
• Chur 7000 Switzerland

• Hôpital Fribourg HFR
• Fribourg 1708 Switzerland

• Kantonsspital Liestal
• Liestal CH-4410 Switzerland

• Fondazione Oncologia / Oncologia ematologia
• Locarno 6600 Switzerland

• Kantonsspital Muensterlingen
• Münsterlingen 8596 Switzerland

• Hôpital du Valais (Sion et Martigny)
• Sion 1951 Switzerland

• Kantonsspital – St. Gallen
• St. Gallen CH-9007 Switzerland

• Spital STS AG
• Thun CH-3600 Switzerland

View trial on ClinicalTrials.gov