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Prostate Cancer MetastaticPhase 2NCT02933801

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

A Phase 2 study testing ODM-201 in people with Prostate Cancer Metastatic and Prostate Cancer, run by Swiss Cancer Institute at 32 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic, Prostate Cancer
What is being tested?
ODM-201
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
32 sitesin 4 countries
Study dates
31 Mar 2017to 15 Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

Spain10 sites

  • Hospital de Torrecárdenas

    Almería, 04009

  • Hospital Universitario Infanta Cristina

    Badajoz, 06080

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, 12002

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Hospital Univ. de Guadalajara

    Guadalajara, 19002

  • Centro Integral Oncológico Clara Campal - Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, 28222

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Complejo Hospital Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

Other trials in Spain

Switzerland10 sites

  • Kantonsspital Baden

    Baden, CH-5404

  • Istituto Oncologico della Svizzera Italiana (IOSI)

    Bellinzona, 6500

  • Kantonsspital Graubuenden

    Chur, 7000

  • Hôpital Fribourg HFR

    Fribourg, 1708

  • Kantonsspital Liestal

    Liestal, CH-4410

  • Fondazione Oncologia / Oncologia ematologia

    Locarno, 6600

  • Kantonsspital Muensterlingen

    Münsterlingen, 8596

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Hôpital du Valais (Sion et Martigny)

    Sion, 1951

  • Spital STS AG

    Thun, CH-3600

Other trials in Switzerland

Italy8 sites

  • European Institute of Oncology (EIO)

    Milan, 20141

  • Istituto Nazionale dei Tumori - IRCCS Fondazione

    Milan, 20141

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

    Naples, 80131

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

    Novara, 28100

  • AOU San Luigi Gonzaga

    Orbassano, 10043

  • AO San Camillo and Forlanini Hospitals

    Roma, 00152

  • Presidio Ospedaliero Santa Chiara

    Trento, 38122

  • Azienda Ospedaliera Universitaria Integrate Verona (AOUI)

    Verona, 37126

Other trials in Italy

France4 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Oscar Lambret

    Lille, 59020

  • Centre de lutte contre le cancer Léon Bérard

    Lyon, 69008

  • Centre Eugène Marquis

    Rennes, 35042

Other trials in France

About this study

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.

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.

Read the 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.

Being tested
ODM-201, Placebo
Keywords
metastatic castration resistant prostate cancer (mCRPC), Prostate Cancer, phase II trial, ODM-201, maintenance therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ODM-201Drug

    Also called BAY-1841788

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

  • PlaceboOther

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

Study groups in NCT02933801
Study groupRoleWhat they receive
Arm A: ODM-201Experimental600mg ODM-201 BID (twice daily) and Best Supportive Care until progression
Receives: Drug: ODM-201
Arm B: PlaceboPlacebo comparatorPlacebo BID (twice daily) and Best Supportive Care until progression
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 12 weeks after treatment start

Secondary outcomes (6)

  1. Radiographic progression-free survival (rPFS)

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

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

  2. Time to PSA progression

    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

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

  3. Time to symptomatic/clinical progression

    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)

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

  4. Event-free survival

    Event-free survival is defined as the time from treatment start until the event of interest.

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

  5. Overall survival

    Overall survival is defined as the time from treatment start until death from any cause.

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

  6. PSA response (30%, 50%, 90% and best)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2016 (estimated)
  2. Study start31 Mar 2017
  3. Primary completion28 Jun 2021
  4. Study completion15 Nov 2023

Why it stopped: Decision Board no further financial support after 3 years of follow-up as remaining patients in follow-up phase would not relevantly change the endpoints.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02933801
Sponsor's protocol ID
SAKK 08/16
Other IDs
2016-003996-23, 2016
Status last verified
Mar 2024
First submitted
13 Oct 2016
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36753698

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ODM-201 in people with Prostate Cancer Metastatic and Prostate Cancer, run by Swiss Cancer Institute at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Spain, Switzerland, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Decision Board no further financial support after 3 years of follow-up as remaining patients in follow-up phase would not relevantly change the endpoints.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic progression-free survival (rPFS) at 12 weeks (time frame: At 12 weeks after treatment start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02933801, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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