Prostate CancerPhase 3NCT01707966
Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer and Non-progressive Disease After First-line Docetaxel Therapy
A Phase 3 study testing Orteronel in people with Prostate Cancer, run by Swiss Cancer Institute at 15 sites in Switzerland.
Trial summary
The main objective of this multicenter, randomized, double-blind, placebo-controlled phase III trial is to assess the impact of maintenance orteronel on disease progression and hence on quality of life in patients with metastatic castration-resistant prostate cancer who have achieved at lease disease stabilization… 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
- 47 participants
- Where
- 15 sitesSwitzerland
- Study dates
- Sep 2012to Jul 2016
- 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
- Male patient 18 years or older
- WHO performance status of ≤2
- Adenocarcinoma of the prostate
- Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues
- Metastatic disease, radiographically documented (
Show all 19Show fewer
- Total testosterone ≤ 50 ng/dL
- Non-progressive disease after docetaxel first-line treatment with a cumulative dose ≥ 300mg/m2
- No evidence of progression on imaging according to PCWG2 and modified RECIST 1.1 criteria
- PSA levels not elevated ≥ 25% AND at least 2 ng/mL above the nadir since start of docetaxel treatment
- Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
- PSA ≥ 2 ng/mL; Potassium ≥ 3.5 mmol/L; Neutrophils ≥ 1.5 x 109/L; Platelets ≥ 100 x 10x9/L
- Normal kidney and liver function
- Planned start of trial treatment 3 to 6 weeks after last docetaxel administration
- Screening calculated ejection fraction of ≥ 50% or normal according to local standard by echocardiogram or by multiple gated acquisition (MUGA) scan.
- 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 agrees to practice effective barrier contraception or to completely abstain from intercourse
Who cannot join
- Prior therapy with aminoglutethimide, ketoconazole, orteronel, abiraterone or other modern CYP17 inhibitors
- Prior chemotherapy for prostate cancer within 12 months before enrollment except from docetaxel
- Retreatment with docetaxel after interruption of > 5 weeks
- Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
- Known hypersensitivity to trial drug or hypersensitivity to any of its components
- Patient has received other investigational drugs within 30 days before enrollment
Show all 20Show fewer
- 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
- Diagnosed or treated for another malignancy within 2 years of registration, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, or any in situ malignancies
- 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) within 6 months prior to 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
- 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 or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Switzerland15 sites
Kantonspital Aarau
Aarau, CH-5001
Universitaetsspital Basel
Basel, 4031
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, 6500
Inselspital Bern
Bern, CH-3010
Kantonsspital Graubuenden
Chur, 7000
Kantonsspital Freiburg
Fribourg, 1708
Hôpitaux Universitaires de Genève HUG
Geneva, 1211
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, CH-1011
Kantonsspital Luzern
Lucerne, 6000
Spital Männedorf
Männedorf, 8708
Kantonsspital Muensterlingen
Münsterlingen, 8596
Kantonsspital St. Gallen
Sankt Gallen, 9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, 3600
Kantonsspital Winterthur
Winterthur, 8401
UniversitaetsSpital Zuerich
Zurich, 8091
About this study
Official title: Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer and Non-progressive Disease After First-line Docetaxel Therapy: a Multicenter Randomized Double-blind Placebo-controlled Phase III Trial.
The main objective of this multicenter, randomized, double-blind, placebo-controlled phase III trial is to assess the impact of maintenance orteronel on disease progression and hence on quality of life in patients with metastatic castration-resistant prostate cancer who have achieved at lease disease stabilization after first line chemotherapy with docetaxel.
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 approximately 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.
Metastatic prostate cancer is hormone-sensitive and therefore androgen deprivation therapy (ADT) is the treatment of choice. Yet, virtually all patients with metastatic prostate cancer progress on androgen deprivation therapy (so called castration-resistant prostate cancer: CRPC). Further hormonal manipulations are often administered (e.g. maximal androgen blockade with addition of a non-steroidal antiandrogen such as bicalutamide), however these interventions have only modest impact. Metastatic CRPC (mCRPC) that progresses despite these therapies is nowadays treated with docetaxel-based chemotherapy. In a phase III trial, treatment of mCRPC patients with docetaxel in combination with low dose prednisone resulted in a significant survival advantage in comparison to the previous standard of care of mitoxantrone plus prednisone. Moreover docetaxel treatment improved response rate, progression free survival and symptom control.
The current standard of care in patients with disease stabilization after first line chemotherapy with docetaxel is a wait-and-watch strategy, where patients are regularly examined in the hospital every 3-4 weeks. A second line chemotherapy in patients with mCRPC was not standardized until recently. However, two trials presented in 2010 have changed the landscape: the novel taxane cabazitaxel was tested in a phase III trial against mitoxantrone as a second line chemotherapy in patients progressing under or after docetaxel. There was a significant improvement in overall survival, progression free survival and response rate. Most of the included patients had experienced disease progression during or within three months of docetaxel first line treatment. Cabazitaxel was associated with increased toxicity including 5% toxic deaths. Another randomized phase III trial using abiraterone in patients with progression after docetaxel showed a significant improvement in overall survival and pain palliation. Abiraterone belongs to a group of agents that very effectively inhibits the androgen synthesis via blockade of the key enzyme cytochrome P-450c17 (CYP17).
The new drug orteronel (TAK-700) belongs to the same group of active substances as abiraterone. Orteronel is currently the subject of a large international Phase III study in patients with metastatic carcinoma of the prostate and progression of disease following docetaxel. Initial results have shown that orteronel effectively inhibits testosterone synthesis and, in contrast to abiraterone, has fewer side effects.
Rational:
CYP17 inhibitors are active and well tolerated agents for treatment of patients with castration-resistant prostate cancer. However, despite its activity patients become resistant to this new form of antihormonal treatment and hence develop further progression after a median of approximately 6 months. In that case, the options are very limited as outlined above.
In all reported post-docetaxel trials and in the large phase III trials, patients start on the CYP17 inhibitor treatment at the time of disease progression. 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.
Therefore, the aim of this trial is to test the hypothesis that starting orteronel after disease stabilization with docetaxel prolongs event-free survival (EFS), consequently maintains a good quality of life (QL) and eventually also improves OS.
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Orteronel and best supportive care | Experimental | Arm A: 300mg Orteronel twice daily and best supportive care until occurrence of an event. Receives: Drug: Orteronel |
| Placebo and best supportive care | Placebo comparator | Arm B: Placebo twice daily and best supportive care until occurrence of an event. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival (EFS)
Measured: At baseline; every 4 weeks until disease progression (estimated up to 1 year)
Secondary outcomes (6)
Adverse events (AEs)
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)
QL and pain response
Measured: First 6 months of trial treatment
Overall survival (OS)
Measured: time from trial randomization to the date of death from any cause (estimated up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 47 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
- NCT01707966
- Sponsor's protocol ID
- SAKK 08/11
- Other IDs
- 2011-002965-39
- Status last verified
- May 2019
- First submitted
- 13 Sep 2012
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cathomas R, Crabb SJ, Mark M, Winterhalder R, Rothermundt C, Elliott T, von Burg P, Kenner H, Hayoz S, Vilei SB, Rauch D, Roggero E, Mohaupt MG, Bernhard J, Manetsch G, Gillessen S; Swiss Group for Clinical Cancer Research SAKK. Orteronel Switch Maintenance Therapy in Metastatic Castration Resistant Prostate Cancer After First-Line Docetaxel: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (SAKK 08/11). Prostate. 2016 Dec;76(16):1519-1527. doi: 10.1002/pros.23236. Epub 2016 Jul 25.
PubMed 27457964
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. 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 and Non-progressive Disease After First-line Docetaxel Therapy: a Multicenter Randomized Double-blind Placebo-controlled Phase III Trial.
- ClinicalTrials.gov ID
- NCT01707966
- Acronym / sponsor ID
- SAKK 08/11
- 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
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Oct 2012 (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 objective of this multicenter, randomized, double-blind, placebo-controlled phase III trial is to assess the impact of maintenance orteronel on disease progression and hence on quality of life in patients with metastatic castration-resistant prostate cancer who have achieved at lease disease stabilization after first line chemotherapy with docetaxel.
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 approximately 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.
Metastatic prostate cancer is hormone-sensitive and therefore androgen deprivation therapy (ADT) is the treatment of choice. Yet, virtually all patients with metastatic prostate cancer progress on androgen deprivation therapy (so called castration-resistant prostate cancer: CRPC). Further hormonal manipulations are often administered (e.g. maximal androgen blockade with addition of a non-steroidal antiandrogen such as bicalutamide), however these interventions have only modest impact. Metastatic CRPC (mCRPC) that progresses despite these therapies is nowadays treated with docetaxel-based chemotherapy. In a phase III trial, treatment of mCRPC patients with docetaxel in combination with low dose prednisone resulted in a significant survival advantage in comparison to the previous standard of care of mitoxantrone plus prednisone. Moreover docetaxel treatment improved response rate, progression free survival and symptom control.
The current standard of care in patients with disease stabilization after first line chemotherapy with docetaxel is a wait-and-watch strategy, where patients are regularly examined in the hospital every 3-4 weeks. A second line chemotherapy in patients with mCRPC was not standardized until recently. However, two trials presented in 2010 have changed the landscape: the novel taxane cabazitaxel was tested in a phase III trial against mitoxantrone as a second line chemotherapy in patients progressing under or after docetaxel. There was a significant improvement in overall survival, progression free survival and response rate. Most of the included patients had experienced disease progression during or within three months of docetaxel first line treatment. Cabazitaxel was associated with increased toxicity including 5% toxic deaths. Another randomized phase III trial using abiraterone in patients with progression after docetaxel showed a significant improvement in overall survival and pain palliation. Abiraterone belongs to a group of agents that very effectively inhibits the androgen synthesis via blockade of the key enzyme cytochrome P-450c17 (CYP17).
The new drug orteronel (TAK-700) belongs to the same group of active substances as abiraterone. Orteronel is currently the subject of a large international Phase III study in patients with metastatic carcinoma of the prostate and progression of disease following docetaxel. Initial results have shown that orteronel effectively inhibits testosterone synthesis and, in contrast to abiraterone, has fewer side effects.
Rational:
CYP17 inhibitors are active and well tolerated agents for treatment of patients with castration-resistant prostate cancer. However, despite its activity patients become resistant to this new form of antihormonal treatment and hence develop further progression after a median of approximately 6 months. In that case, the options are very limited as outlined above.
In all reported post-docetaxel trials and in the large phase III trials, patients start on the CYP17 inhibitor treatment at the time of disease progression. 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.
Therefore, the aim of this trial is to test the hypothesis that starting orteronel after disease stabilization with docetaxel prolongs event-free survival (EFS), consequently maintains a good quality of life (QL) and eventually also improves OS.
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 |
|---|---|---|
| Orteronel and best supportive care | Experimental | Drug: OrteronelArm A: 300mg Orteronel twice daily and best supportive care until occurrence of an event. |
| Placebo and best supportive care | Placebo comparator | Drug: PlaceboArm B: Placebo twice daily and best supportive care until occurrence of an event. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient has given voluntary written informed consent
- Male patient 18 years or older
- WHO performance status of ≤2
- Adenocarcinoma of the prostate
- Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues
Key exclusion criteria (20 listed)
- Prior therapy with aminoglutethimide, ketoconazole, orteronel, abiraterone or other modern CYP17 inhibitors
- Prior chemotherapy for prostate cancer within 12 months before enrollment except from docetaxel
- Retreatment with docetaxel after interruption of > 5 weeks
- Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
- Known hypersensitivity to trial drug or hypersensitivity to any of its components
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-700 | Drug | Orteronel and best supportive care |
| Placebo | Drug | Placebo and best supportive care |
Primary outcome
Event free survival (EFS)
Time frame: At baseline; every 4 weeks until disease progression (estimated up to 1 year)
6 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)
QL and pain response
Time frame: First 6 months of trial treatment
Overall survival (OS)
Time frame: time from trial randomization to the date of death from any cause (estimated up to 4 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Results publication: PubMed 27457964Cathomas R, Crabb SJ, Mark M, Winterhalder R, Rothermundt C, Elliott T, von Burg P, Kenner H, Hayoz S, Vilei SB, Rauch D, Roggero E, Mohaupt MG, Bernhard J, Manetsch G, Gillessen S; Swiss Group for Clinical Cancer Research SAKK. Orteronel Switch Maintenance Therapy in Metastatic Castration Resistant Prostate Cancer After First-Line Docetaxel: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (SAKK 08/11). Prostate. 2016 Dec;76(16):1519-1527. doi: 10.1002/pros.23236. Epub 2016 Jul 25.
- 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
15 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 15 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 19 inclusion and 20 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: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (EFS) (time frame: At baseline; every 4 weeks until disease progression (estimated up to 1 year)). 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 NCT01707966, 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 15 May 2019.