Prostate Cancer MetastaticPhase 2/3OSTRIChNCT03295565
Optimal Sequencing of Treatment Options for Poor Risk mCRPC Previously Treated With Docetaxel
A Phase 2/3 study testing Cabazitaxel, Abiraterone and Enzalutamide in people with Prostate Cancer Metastatic and Metastasis, run by The Netherlands Cancer Institute at 19 sites in Netherlands.
Trial summary
Rationale: The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic, Metastasis
- What is being tested?
- Cabazitaxel, Abiraterone and Enzalutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 19 sitesNetherlands
- Study dates
- 7 May 2017to 2 Mar 2022
- Phase
- Phase 2/3
- 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
- Histological diagnosis of prostate adenocarcinoma.
- Able and willing to provide informed consent and to comply with the study procedures
- Age ≥18
- Evidence of bone, visceral and/or lymph node metastases on bone scan, CT-scan or MRI.
- Must have received at least one prior regimen of docetaxel treatment for at least 12 weeks (four courses) and no other prostate cancer treatments between docetaxel and randomization, other than prednisone.
- Continued androgen deprivation therapy either by luteinizing hormone release hormone (LHRH) agonist/ antagonist or orchiectomy.
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- Treatment with curative intent is not an option and patient has an indication for systemic treatment as judged by the medical care provider
- Evidence of progressive metastatic disease by PSA progression (Prostate Cancer Working Group 3 (PCWG3) criteria20: at least 2 rises at a minimum of 1-week intervals. The first PSA value must be ≥ 2 ng/ml) and/or radiological progression as evaluated by chest, abdominal, or pelvic CT/MRI scan and/or bone scan within 28 days of registration (see Appendix III)
- Poor prognosis disease as defined by any of the following:
- The presence of liver metastases AND/OR
- Development of castration-resistance within 12 months of orchiectomy or commencement of LHRH antagonist/agonist for metastatic disease AND/OR
- Progressive disease during docetaxel treatment or <6 months after completion of docetaxel treatment
- World Health Organization Performance Status (WHO PS) 0-2.
- Serum testosterone < 50 ng/dL (< 1.7 nmol/L) within 28 days before treatment group allocation
- At least 21 days have passed since completing radiotherapy (exception for a single fraction of ≤ 800 centi-Gray (cGy) to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit: at least 7 days prior to randomization).
- At least 21 days have passed since major surgery.
- Neuropathy ≤ grade 1 at the time of registration.
- Has recovered from all therapy-related toxicity to ≤ grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) at the time of registration.
- Eligible for cabazitaxel, abiraterone acetate or enzalutamide as per standard of care practices.
- Men treated with cabazitaxel should use effective contraception throughout treatment and are recommended to continue this for up to 6 months after the last dose of cabazitaxel. Due to potential exposure via seminal liquid, men treated with cabazitaxel should prevent contact with the ejaculate by another person throughout treatment. Men being treated with cabazitaxel are advised to seek advice on conservation of sperm prior to treatment.
Who cannot join
- Histologic evidence of small cell/neuroendocrine prostate cancer
- Any treatment other than prednisone between docetaxel and cabazitaxel/abiraterone OR enzalutamide sequence
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus).
- History of severe hypersensitivity reaction (≥ grade 3) to docetaxel, abiraterone or enzalutamide (whichever applies).
- History of severe hypersensitivity reaction (≥ grade 3) to polysorbate 80 containing drugs.
- Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments).
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- Patients who have a concurrent yellow fever vaccination (several weeks before start of treatment) must be excluded.
- Dementia, altered mental status, or any psychiatric condition, if this is in conflict with the study.
- Unable to swallow a whole tablet or capsule
- Contraindications to the use of corticosteroid treatment
- Symptomatic peripheral neuropathy Grade ≥2 (see Appendix VIII).
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured and needing no subsequent therapy.
- Inadequate organ and bone marrow function as evidenced by:
- Hemoglobin <10.0 g/dL
- Absolute neutrophil count <1.5 x 109/L
- Platelet count < 100 x 109/L
- aspartate aminotransferase (AST)/ serum glutamate oxaloacetate transaminase (SGOT) and/ or Alanine Aminotransferase (ALT)/ serum glutamate pyruvate transaminase (SGPT) > 1.5 x (upper limit of normal) ULN Total bilirubin >1 x ULN (except for patients with documented Gilbert's disease).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Netherlands19 sites
Noordwest Ziekenhuisgroep
Alkmaar
Bovenij ziekenhuis
Amsterdam
Rode Kruis Ziekenhuis
Beverwijk, 1940 EB
Tergooi Ziekenhuizen
Blaricum
Deventer Ziekenhuis
Deventer
Slngeland Ziekenhuis
Doetinchem
Ziekenhuisgroep Twente
Hengelo
Spaarne Ziekenhuis
Hoofddorp
Dijklander ziekenhuis
Hoorn
Medisch Centrum leeuwarden
Leeuwarden
Academisch medisch centrum Maastricht
Maastricht
Sint Antonius ziekenhuis
Nieuwegein
Franciscus Gasthuis-Vlietland
Rotterdam
Zorgsaam Ziekenhuis
Terneuzen
Haga Ziekenhuis
The Hague
Diakonessenhuis
Utrecht
Universitair medisch centrum Utrecht
Utrecht
Viecuri medisch centrum Noord-Limburg
Venlo
Isala Klinieken
Zwolle
About this study
Official title: A Randomized, Open Label, Phase IIB Trial of Optimal Sequencing of Treatment Options for Poor Risk Metastasized Castration Resistant Prostate Cancer Previously Treated With Docetaxel
Rationale:
The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life.
Read more
Objective:
The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B).
Intervention:
Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive abiraterone and prednisone OR enzalutamide.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and are reimbursed. Risk of side effects or death as a result of treatment is not affected by the trial design. At baseline, prior to each treatment cycle and at end of treatment, patients are requested to visit the out-patient clinic, where a physical exam will be performed in combination with vena puncture for blood analysis. Radiological evaluation will be performed at base line, after 3 months of treatment and at end of treatment. All above mentioned interventions can be considered as standard practice. Patients are requested to fill out QoL and pain/analgesic use questionnaires at base line, prior to each cycle and at end of treatment.
Read the detailed description
Rationale:
The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life.
Objective:
The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B).
Study design:
a prospective, multicenter, national, randomized, open label phase IIB study. Study population: Males over 18 years with mCRPC, previously treated with docetaxel and features of poor prognostic disease; including duration of response to androgen deprivation shorter than one year, liver metastases, disease progression during docetaxel treatment or within 6 months after docetaxel treatment completion.
Intervention:
Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive abiraterone and prednisone OR enzalutamide.
Main study parameters/endpoints: Primary endpoint: Clinical benefit rate (CBR). Secondary endpoints include: formal comparison of the CBR in both study arms, Time To Symptomatic Progression (TTSP), Time To PSA (prostate specific antigen), Progression (TTPP), and Time To Radiologic Progression (TTRP), progression free survival, overall survival, safety/ toxicity profile and Quality of Life (QoL) and pain response.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and are reimbursed. Risk of side effects or death as a result of treatment is not affected by the trial design. At baseline, prior to each treatment cycle and at end of treatment, patients are requested to visit the out-patient clinic, where a physical exam will be performed in combination with vena puncture for blood analysis. Radiological evaluation will be performed at base line, after 3 months of treatment and at end of treatment. All above mentioned interventions can be considered as standard practice. Patients are requested to fill out QoL and pain/analgesic use questionnaires at base line, prior to each cycle and at end of treatment.
- Conditions
- Prostate Cancer Metastatic, Metastasis
- Being tested
- Cabazitaxel, Abiraterone, Enzalutamide
- Keywords
- Sequencing, cabazitaxel, abiraterone, enzalutamide, clinical benefit rate, docetaxel, second line treatment
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called No other intervention names
Cabazitaxel 25mg/m2 IV, once every 3 weeks
AbirateroneDrug
Also called No other intervention names
Abiraterone 1000mg oral, taken daily + Prednisone 5mg oral, 2 times a day
EnzalutamideDrug
Also called No other intervention names
Enzalutamide 160mg oral taken daily
| Study group | Role | What they receive |
|---|---|---|
| A: Cabazitaxel | Active comparator | Cabazitaxel 25mg/m2 IV, once every 3 weeks Receives: Drug: Cabazitaxel |
| B: Abiraterone OR Enzalutamide | Active comparator | At physician's discretion:
Abiraterone 1000mg oral, taken daily Prednisone 5mg oral, 2 times a day OR Enzalutamide 160mg oral taken daily Receives: Drug: Abiraterone; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate
- To assess the Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel (Arm A) or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B) who have been treated with docetaxel.
Measured: From start treatment until 12 weeks of treatment
Secondary outcomes (12)
Comparing clinical benefit rate in arm A and arm B
- To formally compare the Clinical Benefit Rate (CBR) in both study arms A and B.
Measured: From start treatment until 12 weeks of treatment
Duration of treatment
- To determine duration of treatment (DOT) in mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.
Measured: for each patient; until end of treatment (for Arm A max 30 weeks, for Arm B max 24 months)
Progression free survival
- To determine the Progression Free Survival (PFS) of mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.
Measured: for each patient; until progression or through study completion (max 24 months)
Overall survival
- To determine the Overall Survival (OS) of mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy.
Measured: for each patient; until death or end of trial (max 24 months)
(serious) adverse events according to the ctcae v4.03: number of incidents, number of participants with (S)AE's
- To evaluate safety and toxicity profile of cabazitaxel and novel hormone agents (abiraterone OR enzalutamide) as a second line treatment.
Measured: for each patient: until 28 days after the last treatment
Quality of Life assesed by the FACT-P questionnaire
- Quality of Life (QoL) as assessed by Fundamental Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire in metastatic CRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy.
Measured: for each patient; until start of the next therapy, death or end of trial (max 24 months)
Quality of Life as assessed by the BPI-S questionnaire
- Quality of Life (QoL) as assessed Brief Pain Inventory-Short form (BPI-S) questionnaire in metastatic CRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy.
Measured: for each patient; until start of the next therapy, death or end of trial (max 24 months)
Use of pain medication, assessed by a questionnaire about opiate use.
Use of pain medication, assessed by a questionnaire about opiate use in metastatic CRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy.
Measured: for each patient; until start of the next therapy, death or end of trial (max 24 months)
Time to symptomatic progression
Time To Symptomatic Progression (TTSP) in CRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.
Measured: for each patient: until symptomatic progression or through study completion (max 24 months)
Time to PSA progression
Time To PSA Progression (TTPP) in mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.
Measured: for each patient: until PSA progression or through study completion (max 24 months)
Time to Radiological progression
Time To Radiological Progression (TTRP) in mCRPC patients treated with cabazitaxel or novel hormone agents (abiraterone OR enzalutamide) as second-line therapy and for those who cross over to the other study arm as a third-line therapy.
Measured: for each patient: until radiological progression or through study completion (max 24 months)
PSA>50% decrease
Rate of PSA>50% decrease from baseline
Measured: for each patient; from baseline until end of trial (max 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start7 May 2017
- Primary completion16 Dec 2020
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- randomized, open label, Phase IIB trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295565
- Sponsor's protocol ID
- m16OST
- Acronym
- OSTRICh
- Status last verified
- Apr 2022
- First submitted
- 17 Jul 2017
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Phase IIB Trial of Optimal Sequencing of Treatment Options for Poor Risk Metastasized Castration Resistant Prostate Cancer Previously Treated With Docetaxel
- ClinicalTrials.gov ID
- NCT03295565
- Acronym / sponsor ID
- OSTRICh / m16OST
- Conditions
- Prostate Cancer Metastatic, Metastasis
- Keywords
- Sequencing, cabazitaxel, abiraterone, enzalutamide, clinical benefit rate, docetaxel, second line treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 7 May 2017 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 28 Sep 2017 (actual)
- 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.
Rationale:
The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life.
Objective:
The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B).
Intervention:
Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive abiraterone and prednisone OR enzalutamide.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and are reimbursed. Risk of side effects or death as a result of treatment is not affected by the trial design. At baseline, prior to each treatment cycle and at end of treatment, patients are requested to visit the out-patient clinic, where a physical exam will be performed in combination with vena puncture for blood analysis. Radiological evaluation will be performed at base line, after 3 months of treatment and at end of treatment. All above mentioned interventions can be considered as standard practice. Patients are requested to fill out QoL and pain/analgesic use questionnaires at base line, prior to each cycle and at end of treatment.
Detailed description
Rationale:
The aim of this study is to identify the optimal second line treatment option for patients with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect to Clinical Benefit Rate (CBR) rate and quality of life.
Objective:
The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B).
Study design:
a prospective, multicenter, national, randomized, open label phase IIB study. Study population: Males over 18 years with mCRPC, previously treated with docetaxel and features of poor prognostic disease; including duration of response to androgen deprivation shorter than one year, liver metastases, disease progression during docetaxel treatment or within 6 months after docetaxel treatment completion.
Intervention:
Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive abiraterone and prednisone OR enzalutamide.
Main study parameters/endpoints: Primary endpoint: Clinical benefit rate (CBR). Secondary endpoints include: formal comparison of the CBR in both study arms, Time To Symptomatic Progression (TTSP), Time To PSA (prostate specific antigen), Progression (TTPP), and Time To Radiologic Progression (TTRP), progression free survival, overall survival, safety/ toxicity profile and Quality of Life (QoL) and pain response.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and are reimbursed. Risk of side effects or death as a result of treatment is not affected by the trial design. At baseline, prior to each treatment cycle and at end of treatment, patients are requested to visit the out-patient clinic, where a physical exam will be performed in combination with vena puncture for blood analysis. Radiological evaluation will be performed at base line, after 3 months of treatment and at end of treatment. All above mentioned interventions can be considered as standard practice. Patients are requested to fill out QoL and pain/analgesic use questionnaires at base line, prior to each cycle and at end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, open label, Phase IIB trial
| Arm | Type | Receives |
|---|---|---|
| A: Cabazitaxel | Active comparator | Drug: CabazitaxelCabazitaxel 25mg/m2 IV, once every 3 weeks |
| B: Abiraterone OR Enzalutamide | Active comparator | Drug: Abiraterone, Drug: EnzalutamideAt physician's discretion: Abiraterone 1000mg oral, taken daily Prednisone 5mg oral, 2 times a day OR Enzalutamide 160mg oral taken daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histological diagnosis of prostate adenocarcinoma.
- Able and willing to provide informed consent and to comply with the study procedures
- Age ≥18
- Evidence of bone, visceral and/or lymph node metastases on bone scan, CT-scan or MRI.
- Must have received at least one prior regimen of docetaxel treatment for at least 12 weeks (four courses) and no other prostate cancer treatments between docetaxel and randomization, other than prednisone.
Key exclusion criteria (17 listed)
- Histologic evidence of small cell/neuroendocrine prostate cancer
- Any treatment other than prednisone between docetaxel and cabazitaxel/abiraterone OR enzalutamide sequence
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus).
- History of severe hypersensitivity reaction (≥ grade 3) to docetaxel, abiraterone or enzalutamide (whichever applies).
- History of severe hypersensitivity reaction (≥ grade 3) to polysorbate 80 containing drugs.
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 |
|---|---|---|
| CabazitaxelAlso: No other intervention namesCabazitaxel 25mg/m2 IV, once every 3 weeks | Drug | A: Cabazitaxel |
| AbirateroneAlso: No other intervention namesAbiraterone 1000mg oral, taken daily + Prednisone 5mg oral, 2 times a day | Drug | B: Abiraterone OR Enzalutamide |
| EnzalutamideAlso: No other intervention namesEnzalutamide 160mg oral taken daily | Drug | B: Abiraterone OR Enzalutamide |
Primary outcome
Clinical benefit rate
Time frame: From start treatment until 12 weeks of treatment
• To assess the Clinical Benefit Rate (CBR) in patients with mCRPC and poor prognostic factors treated with cabazitaxel (Arm A) or novel hormonal agents (abiraterone OR enzalutamide) as second-line therapy (Arm B) who have been treated with docetaxel.
12 secondary outcomes
Comparing clinical benefit rate in arm A and arm B
Time frame: From start treatment until 12 weeks of treatment
Duration of treatment
Time frame: for each patient; until end of treatment (for Arm A max 30 weeks, for Arm B max 24 months)
Progression free survival
Time frame: for each patient; until progression or through study completion (max 24 months)
Overall survival
Time frame: for each patient; until death or end of trial (max 24 months)
(serious) adverse events according to the ctcae v4.03: number of incidents, number of participants with (S)AE's
Time frame: for each patient: until 28 days after the last treatment
Quality of Life assesed by the FACT-P questionnaire
Time frame: for each patient; until start of the next therapy, death or end of trial (max 24 months)
Quality of Life as assessed by the BPI-S questionnaire
Time frame: for each patient; until start of the next therapy, death or end of trial (max 24 months)
Use of pain medication, assessed by a questionnaire about opiate use.
Time frame: for each patient; until start of the next therapy, death or end of trial (max 24 months)
Time to symptomatic progression
Time frame: for each patient: until symptomatic progression or through study completion (max 24 months)
Time to PSA progression
Time frame: for each patient: until PSA progression or through study completion (max 24 months)
Time to Radiological progression
Time frame: for each patient: until radiological progression or through study completion (max 24 months)
PSA>50% decrease
Time frame: for each patient; from baseline until end of trial (max 24 months)
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 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cabazitaxel, Abiraterone and Enzalutamide in people with Prostate Cancer Metastatic and Metastasis, run by The Netherlands Cancer Institute at 19 sites in Netherlands.
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 20 inclusion and 17 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Netherlands. 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 combined 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.
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?
Clinical benefit rate (time frame: From start treatment until 12 weeks of treatment). 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 15 Apr 2022.