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

NCT02933801 | Terminated Phase 2 DMC

• 2 other identifiers: SAKK 08/162016-003996-23
• Study Type: interventional
• Target: 92
• Locations: 4 countries
• Sites: 32

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.

Conditions

Prostate Cancer Metastatic; Prostate Cancer

Keywords

metastatic castration resistant prostate cancer (mCRPC); Prostate Cancer; phase II trial; ODM-201; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Radiographic progression-free survival (rPFS) at 12 weeks

  Radiographic progression-free survival is defined as the time from treatment start to radiographic disease progression or death from any cause, whichever occurs earlier.

  At 12 weeks after treatment start

Secondary Outcomes (6)

• Radiographic progression-free survival (rPFS)

  Every 12 weeks until disease progression (estimated up to 1 year)

• Time to PSA progression

  PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)

• Time to symptomatic/clinical progression

  treatment start to the time point of symptomatic/clinical progression (estimated up to 1 year)

• Event-free survival

  treatment start until the event of interest (estimated up to 1 year)

• Overall survival

  time from trial randomization to the date of death from any cause (estimated up to 6 years)

Study Arms (2)

Arm A: ODM-201

EXPERIMENTAL

600mg ODM-201 BID (twice daily) and Best Supportive Care until progression

Drug: ODM-201

Arm B: Placebo

PLACEBO COMPARATOR

Placebo BID (twice daily) and Best Supportive Care until progression

Other: Placebo

Interventions

ODM-201 DRUG

ODM-201 will be given at a dose of 600 mg BID orally on a continuous basis.

Also known as: BAY-1841788

Arm A: ODM-201

Placebo OTHER

Placebo will be given at a dose of 600 mg BID orally on a continuous basis.

Arm B: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (32)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre de lutte contre le cancer Léon Bérard

Lyon, 69008, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

European Institute of Oncology (EIO)

Milan, 20141, Italy

Location

Istituto Nazionale dei Tumori - IRCCS Fondazione

Milan, 20141, Italy

Location

Istituto Nazionale dei Tumori - IRCCS Fondazione Pascale S.C.

Napoli, 80131, Italy

Location

AOU "Maggiore della Carità" di S.C. di Oncologia

Novara, 28100, Italy

Location

AOU San Luigi Gonzaga

Orbassano, 10043, Italy

Location

AO San Camillo and Forlanini Hospitals

Roma, 00152, Italy

Location

Presidio Ospedaliero Santa Chiara

Trento, 38122, Italy

Location

Azienda Ospedaliera Universitaria Integrate Verona (AOUI)

Verona, 37126, Italy

Location

Hospital de Torrecárdenas

Almería, 04009, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, 06080, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Castellon, 12002, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Univ. de Guadalajara

Guadalajara, 19002, Spain

Location

Centro Integral Oncológico Clara Campal - Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, 28222, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Complejo Hospital Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Istituto Oncologico della Svizzera Italiana (IOSI)

Bellinzona, 6500, Switzerland

Location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Hôpital Fribourg HFR

Fribourg, 1708, Switzerland

Location

Kantonsspital Liestal

Liestal, CH-4410, Switzerland

Location

Fondazione Oncologia / Oncologia ematologia

Locarno, 6600, Switzerland

Location

Kantonsspital Muensterlingen

Münsterlingen, 8596, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Hôpital du Valais (Sion et Martigny)

Sion, 1951, Switzerland

Location

Spital STS AG

Thun, CH-3600, Switzerland

Location

Related Publications (1)

• Gillessen S, Procopio G, Hayoz S, Kremer E, Schwitter M, Caffo O, Lorente D, Pedrazzini A, Roubaud G, Nenan S, Omlin A, Buttigliero C, Delgado Mingorance JI, Gonzalez-Del-Alba A, Delgado MT, Nole F, Turco F, Pereira Mestre R, Ribi K, Cathomas R. Darolutamide Maintenance in Patients With Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16). J Clin Oncol. 2023 Jul 10;41(20):3608-3615. doi: 10.1200/JCO.22.01726. Epub 2023 Feb 8.

  PMID: 36753698 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Silke Gillessen, Prof

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 14, 2016
• Study Start: March 31, 2017
• Primary Completion: June 28, 2021
• Study Completion: November 15, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (10); ES (10); IT (8); FR (4)