Prostate CancerPhase 3NCT02053311
Orteronel Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents
A Phase 3 study testing Orteronel in people with Prostate Cancer, run by Swiss Cancer Institute at 7 sites in Switzerland.
Trial summary
The main object of this multicenter, randomized, double-blind, placebo-controlled phase III trial is to assess impact of maintenance of orteronel on disease progression and hence on quality of life of patients with metastatic castration resistant prostate cancer pretreated with novel hormonal agents who have… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Orteronel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 7 sitesSwitzerland
- Study dates
- 19 Aug 2014to 19 Aug 2034
- Phase
- Phase 3
- 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
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Male patient 18 years or older
- WHO performance status of ≤2
- Adenocarcinoma of the prostate, histologically or cytologically confirmed
- Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
- Metastatic disease, radiographically documented (CT/MRI, bone scan)
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- Total testosterone ≤ 50 ng/dL (≤ 1.7 nmol/L)
- Treatment with a CYP17 inhibitor or a novel antiandrogen (such as enzalutamide, ODM-201, ARN-509, but not restricted to) or the combination of both agents) for at least 8 weeks prior to one line of a taxane based chemotherapy.
- No evidence of disease progression after chemotherapy with docetaxel (cumulative dose of ≥ 450 mg/m2 or total dose ≥900mg) or cabazitaxel (cumulative dose of ≥150 mg/m2 or total dose ≥300mg)
- Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
- Laboratory values as specified below
- Potassium ≥ 3.5 mmol/L
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Total bilirubin ≤ 1.5 x ULN (except for patient with Gilbert's disease ≤ 5.0 x ULN)
- Estimated creatinine clearance using the Cockcroft-Gault formula > 40 mL/minute
- Planned start of trial treatment 2 to 8 weeks after last taxane dose
- Calculated ejection fraction of ≥ 50% or normal according to local standard by echocardiogram or by multiple gated acquisition (MUGA) scan.
- Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before expected start of treatment
- Patient is able and willing to complete Baseline QL questionnaire completed
- Patient is able and willing to swallow study drug as whole tablet
- Patient compliance and geographic proximity allow proper staging and follow-up
- Patient, even if surgically sterilized (i.e., status post vasectomy)
- agrees to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or
- agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient.
Who cannot join
- Prior therapy with aminoglutethimide and/or ketoconazole
- Prior chemotherapy for prostate cancer within 12 months before enrollment except from chemotherapy with a taxane
- Retreatment with a taxane for metastatic prostate cancer after interruption of > 8 weeks
- Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
- Known allergy and/or hypersensitivity and/or any known grade 4 toxicity to modern CYP17 inhibitors and to any of their components and GnRH
- Concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry
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- Presence of a small cell component in histological specimen
- Radiotherapy within the last 2 weeks before expected start of the trial treatment
- Known history of central nervous system (CNS) or spinal cord metastases
- Current spinal cord compression
- Diagnosis of or treatment for another systemic malignancy within 2 years before registration or patient previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any time are not excluded if they have undergone complete resection.
- History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade ≥ 3 (NCI CTCAE version 4.0) or thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events) or any other cardiac condition (e.g. pericardial effusion, restrictive cardiomyopathy) within 6 months before the first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
- New York Heart Association Class III or IV heart failure
- ECG abnormalities of:
- Q-wave infarction, unless identified ≥ 6 months prior to registration
- QTc interval > 460 msec
- Uncontrolled hypertension despite appropriate medical therapy (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mmHg) at 2 separate measurements no more than 60 minutes apart during the Screening visit).
- Likely inability (e.g. due to a Psychiatric disorder) to understand information on trial related topics, to give informed consent, to comply with the protocol, to fill in QL forms and to cooperate fully with the investigator and site personnel
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of orteronel
- Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical illness that could, in the investigator's opinion, potentially interfere with participation in this study
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Switzerland7 sites
Kantonsspital Baden
Baden, CH-5404
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, 6500
Kantonsspital Graubuenden
Chur, CH-7000
Kantonsspital Luzern
Luzerne, CH-6000
Kantonsspital Muensterlingen
Münsterlingen, 8596
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, 3600
About this study
Official title: Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Non-progressive Disease After Treatment With a Taxane: A Multicentre Randomized Double-blind Placebo-controlled Phase III Trial
The main object of this multicenter, randomized, double-blind, placebo-controlled phase III trial is to assess impact of maintenance of orteronel on disease progression and hence on quality of life of patients with metastatic castration resistant prostate cancer pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.
Read the detailed description
Background
One in six men will be diagnosed with cancer of the prostate during his lifetime. Accordingly, prostate cancer is the most common cancer amongst men in the western world. In Switzerland approx. 5'400 men are diagnosed with the disease and 1'300 die of prostate cancer every year. Prostate cancer represents 30% of all cancer diagnoses in men. Despite earlier detection and new treatments the life time risk to die of prostate cancer has remained stable at 3% since 1980.
In metastatic castration-resistant prostate cancer (with progression on antihormonal therapy) the primary standard therapy for a long time consisted of chemotherapy with docetaxel. It was recently shown that treatment with the novel androgen synthesis blocker, abiraterone (Zytiga) before chemotherapy can prolong survival. Abiraterone belongs to a group of agents that very effectively inhibits the androgen synthesis via blockade of the key enzyme cytochrome P-450c17 (CYP17).Similar results have been reported for the new androgen antagonist enzalutamide (Xtandi). Today, therefore, many patients with metastatic castration-resistant prostate cancer (mCRPC) first receive therapy with abiraterone or enzalutamide. After this, chemotherapy with docetaxel (Taxotere) or cabazitaxel (Jevtana) is usually administered if there is any further progression of the disease. After the end of chemotherapy, the patient is regularly checked and, in the event of disease progression, further treatments may be given. These could consist of renewed hormonal therapy or chemotherapy with cabazitaxel. Besides abiraterone, the medicine orteronel also acts by blocking testosterone production via the key enzyme CYP17. By selectively inhibiting the extragonadal synthesis of androgens in either the adrenal cortex or in prostate tumor cells, orteronel, a selective non-steroidal CYP17 inhibitor, may represent a new therapeutic option for patients with CRPC. Initial results have shown that orteronel effectively inhibits testosterone synthesis.
Hypothesis and aim of the study
Since various new options are available for treatment of castration-resistant prostate cancer at present, this raises the question as to the order in which these treatments should best be given. Initial results show that cross-resistance could develop between the new kinds of hormone therapy abiraterone and enzalutamide. There is evidence to suggest that any resistance to hormone treatments could be reversible as a result of prior treatment with chemotherapy. This study is designed to investigate this approach. It is also intended to investigate whether early use of the well-tolerated testosterone synthesis blocker orteronel in patients with mCRPC leads to an increase in the time to the progression of disease. Trials examining other advanced malignant diseases such as lung cancer have shown that initiating an effective treatment earlier in the disease course at the end of a first-line chemotherapy (so called switch maintenance therapy) is beneficial in terms of progression free survival (PFS) but also overall survival (OS). This may also hold true for early administration of antihormonal agents in patients with mCRPC.
Patients who have already received a novel hormonal therapy followed by chemotherapy with a taxane and have experienced a stabilization of disease on this regimen are included in the study. It is also intended to test whether this treatment has a positive influence on the quality of life of patients.
The aim of this trial is to test the hypothesis that using orteronel treatment immediately after cessation of chemotherapy with a taxane can prolong event-free survival (EFS), consequently maintains a good quality of life (QL) and could eventually also improve overall survival for the group of patients pretreated with novel hormonal agents.
- Conditions
- Prostate Cancer
- Being tested
- Orteronel, Placebo
- Keywords
- adenocarcinoma of the prostate, metastatic castration-resistant prostate cancer, maintenance therapy, orteronel, TAK-700
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrteronelDrug
Also called TAK-700
300mg orteronel
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Orteronel | Active comparator | 300mg orteronel twice daily and best supportive care until disease progression Receives: Drug: Orteronel |
| Arm B: Placebo | Active comparator | Placebo twice daily and best supportive care until disease progression Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
The primary endpoint of the trial is EFS. An event is defined as ONE of the following:
- death from any cause
- the presence of radiographic progression AND symptomatic/clinical progression
- the presence of radiographic progression AND PSA progression
- the presence of symptomatic/clinical progression AND PSA progression
Measured: 5 months
Secondary outcomes (7)
Adverse events (AEs)
All AEs will be assessed according to NCI CTCAE v4.0.
Measured: Throughout treatment phase (estimated up to 1 year) until 30 days after last drug administration or prior to start of subsequent anticancer treatment (whichever occurs first)
Prostate-specific antigen (PSA) response (30%, 50%, 90% and best)
Measured: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)
Time to PSA progression
Measured: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)
Radiographic progression-free survival (rPFS)
Measured: Every 12 weeks until disease progression (estimated up to 1 year)
Overall survival (OS)
Measured: time from trial randomization to the date of death from any cause (estimated up to 4 years)
Quality of Life (QL)
Measured: First 6 months of trial treatment
Pain Response
Measured: First 6 months of trial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study start19 Aug 2014
- Primary completion19 Aug 2014
- Study completion19 Aug 2034 (estimated)
Why it stopped: Due to former trials, drug has not demonstrated a clinical profile sufficient to move forward in mCRPC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Cathomas, MD, Study chair, Kantonsspital GraubündenSilke Gillessen, Prof, Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053311
- Sponsor's protocol ID
- SAKK 08/13
- Other IDs
- 2013-004912-23
- Status last verified
- Jul 2018
- First submitted
- 29 Jan 2014
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Non-progressive Disease After Treatment With a Taxane: A Multicentre Randomized Double-blind Placebo-controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT02053311
- Acronym / sponsor ID
- SAKK 08/13
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, metastatic castration-resistant prostate cancer, maintenance therapy, orteronel, TAK-700
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to former trials, drug has not demonstrated a clinical profile sufficient to move forward in mCRPC
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 19 Aug 2014 (actual)
- Primary completion
- 19 Aug 2014 (actual)
- Study completion
- 19 Aug 2034 (estimated)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main object of this multicenter, randomized, double-blind, placebo-controlled phase III trial is to assess impact of maintenance of orteronel on disease progression and hence on quality of life of patients with metastatic castration resistant prostate cancer pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.
Detailed description
Background
One in six men will be diagnosed with cancer of the prostate during his lifetime. Accordingly, prostate cancer is the most common cancer amongst men in the western world. In Switzerland approx. 5'400 men are diagnosed with the disease and 1'300 die of prostate cancer every year. Prostate cancer represents 30% of all cancer diagnoses in men. Despite earlier detection and new treatments the life time risk to die of prostate cancer has remained stable at 3% since 1980.
In metastatic castration-resistant prostate cancer (with progression on antihormonal therapy) the primary standard therapy for a long time consisted of chemotherapy with docetaxel. It was recently shown that treatment with the novel androgen synthesis blocker, abiraterone (Zytiga) before chemotherapy can prolong survival. Abiraterone belongs to a group of agents that very effectively inhibits the androgen synthesis via blockade of the key enzyme cytochrome P-450c17 (CYP17).Similar results have been reported for the new androgen antagonist enzalutamide (Xtandi). Today, therefore, many patients with metastatic castration-resistant prostate cancer (mCRPC) first receive therapy with abiraterone or enzalutamide. After this, chemotherapy with docetaxel (Taxotere) or cabazitaxel (Jevtana) is usually administered if there is any further progression of the disease. After the end of chemotherapy, the patient is regularly checked and, in the event of disease progression, further treatments may be given. These could consist of renewed hormonal therapy or chemotherapy with cabazitaxel. Besides abiraterone, the medicine orteronel also acts by blocking testosterone production via the key enzyme CYP17. By selectively inhibiting the extragonadal synthesis of androgens in either the adrenal cortex or in prostate tumor cells, orteronel, a selective non-steroidal CYP17 inhibitor, may represent a new therapeutic option for patients with CRPC. Initial results have shown that orteronel effectively inhibits testosterone synthesis.
Hypothesis and aim of the study
Since various new options are available for treatment of castration-resistant prostate cancer at present, this raises the question as to the order in which these treatments should best be given. Initial results show that cross-resistance could develop between the new kinds of hormone therapy abiraterone and enzalutamide. There is evidence to suggest that any resistance to hormone treatments could be reversible as a result of prior treatment with chemotherapy. This study is designed to investigate this approach. It is also intended to investigate whether early use of the well-tolerated testosterone synthesis blocker orteronel in patients with mCRPC leads to an increase in the time to the progression of disease. Trials examining other advanced malignant diseases such as lung cancer have shown that initiating an effective treatment earlier in the disease course at the end of a first-line chemotherapy (so called switch maintenance therapy) is beneficial in terms of progression free survival (PFS) but also overall survival (OS). This may also hold true for early administration of antihormonal agents in patients with mCRPC.
Patients who have already received a novel hormonal therapy followed by chemotherapy with a taxane and have experienced a stabilization of disease on this regimen are included in the study. It is also intended to test whether this treatment has a positive influence on the quality of life of patients.
The aim of this trial is to test the hypothesis that using orteronel treatment immediately after cessation of chemotherapy with a taxane can prolong event-free survival (EFS), consequently maintains a good quality of life (QL) and could eventually also improve overall survival for the group of patients pretreated with novel hormonal agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Orteronel | Active comparator | Drug: Orteronel300mg orteronel twice daily and best supportive care until disease progression |
| Arm B: Placebo | Active comparator | Drug: PlaceboPlacebo twice daily and best supportive care until disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Male patient 18 years or older
- WHO performance status of ≤2
- Adenocarcinoma of the prostate, histologically or cytologically confirmed
- Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
Key exclusion criteria (21 listed)
- Prior therapy with aminoglutethimide and/or ketoconazole
- Prior chemotherapy for prostate cancer within 12 months before enrollment except from chemotherapy with a taxane
- Retreatment with a taxane for metastatic prostate cancer after interruption of > 8 weeks
- Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
- Known allergy and/or hypersensitivity and/or any known grade 4 toxicity to modern CYP17 inhibitors and to any of their components and GnRH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrteronelAlso: TAK-700300mg orteronel | Drug | Arm A: Orteronel |
| PlaceboPlacebo | Drug | Arm B: Placebo |
Primary outcome
Event-free survival
Time frame: 5 months
The primary endpoint of the trial is EFS. An event is defined as ONE of the following: * death from any cause * the presence of radiographic progression AND symptomatic/clinical progression * the presence of radiographic progression AND PSA progression * the presence of symptomatic/clinical progression AND PSA progression
7 secondary outcomes
Adverse events (AEs)
Time frame: Throughout treatment phase (estimated up to 1 year) until 30 days after last drug administration or prior to start of subsequent anticancer treatment (whichever occurs first)
Prostate-specific antigen (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)
Time to PSA progression
Time frame: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year)
Radiographic progression-free survival (rPFS)
Time frame: Every 12 weeks until disease progression (estimated up to 1 year)
Overall survival (OS)
Time frame: time from trial randomization to the date of death from any cause (estimated up to 4 years)
Quality of Life (QL)
Time frame: First 6 months of trial treatment
Pain Response
Time frame: First 6 months of trial treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Cathomas, MD study chair
Kantonsspital Graubünden
Silke Gillessen, Prof study chair
Cantonal Hospital of St. Gallen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orteronel in people with Prostate Cancer, run by Swiss Cancer Institute at 7 sites in Switzerland.
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 25 inclusion and 21 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: withdrawn, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Event-free survival (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2018.