Prostatic Neoplasms, Castration-ResistantPhase 2AERANCT03173859
Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients
A Phase 2 study testing Abiraterone and Apalutamide in people with Prostatic Neoplasms, Castration-Resistant, run by University of Athens.
Trial summary
A randomized phase II study comparing the sequential use of abiraterone followed after progression by apalutamide with alternating cycles of abiraterone and apalutamide Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Castration-Resistant
- What is being tested?
- Abiraterone and Apalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to 31 Dec 2020
- 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
- Signed Informed Consent Age >18 years Histologically confirmed metastatic or advanced prostate cancer adenocarcinoma that has received no treatment for the castration resistant disease and has progressed during treatment with complete androgen blockade (luteinizing hormone releasing hormone agonist or antagonist and an antiandrogen eg. Bicalutamide).
- Availability of a representative formalin-fixed, paraffin-embedded tumor specimen (FFPE) that enabled definitive diagnosis of prostate cancer.
- Two rising PSA levels >2ng/ml measured 1 week apart during or following the most recent prior therapy for prostate cancer (PCWG2 criteria) or radiographic evidence of disease progression in bone with or without biochemical disease progression on the basis of the PSA value.
- Ongoing androgen deprivation, with serum testosterone <50ng/dl ECOG performance status 0-1 at screening Adequate hematologic and organ function within 14 days before the first study treatment (hematologic parameters must be assessed >14 days after a prior transfusion, if any) as defined by
- Hemoglobin >9g/dl
- Neutrophils >1500/μL
Show all 15Show fewer
- Platelet count >100000/μL
- Total bilirubin <1,5xULN with the following exception:
- o Patients with known Gilbert syndrome who have serum bilirubin<3xULN
- AST and ALT<2,5xULN with the following exception
- o Patients with bone-only metastasis may have AST<5xULN, provided that ALT <2,5xULN and total bilirubin <1,5xULN
- Serum albumin >3g/dl
- Serum potassium ≥3.5mmol/L
- Serum creatinine <1,5xULN or creatinine clearance of >50ml/min based on Cockcroft-Gault equation
- Agreement by patient and/or partner to use an effective form of contraception including surgical sterilization, reliable barrier method, birth control pills, contraceptive hormone implants or true abstinence and to continue its use for the duration of the study and for 6 months after the last dose of study treatment.
Who cannot join
- Small cell or neuroendocrine prostate carcinoma Inability or unwillingness to swallow pills Malabsorption syndrome or other condition that would interfere with enteral absorption Congenital long QT syndrome or QTc>480msec NYHA Class II to IV heart failure or LVEF <50% or ventricular arrhythmia requiring medication Previous therapy for prostate cancer with CYP17 inhibitors including ketoconazole or investigational agents (VMT-VT-464, Orteronel etc) or novel antiandrogens (enzalutamide of OMD-208) for more than 7 days Presence of visceral metastasis History of another invasive cancer within 3 years from screening, with the exception of fully treated cancers with a remote probability of recurrence Duration of previous Androgen Deprivation Therapy <12months Active infection requiring IV antibiotics
- Clinically significant cardiovascular disease including the following:
- unstable angina,
- myocardial infarction within 6 months from screening, or
- cerebrovascular accident within 6 months from screening Major surgical procedure within 4 weeks prior to initiation of study treatment Treatment with an investigational agent within 4 weeks prior to initiation of study treatment Unresolved, clinical significant toxicity from prior treatment Hypersensitivity reaction to the active pharmaceutical ingredient or any of the tablet components Any medical condition that restrain the patient to comply with study and follow-up procedures Inability to comply with study and follow up procedures
About this study
Official title: A Randomized Phase II Study to Investigate the Efficacy of Rotations Between Abiraterone Acetate and Apalutamide Versus Sequential Administration in Chemo-naïve Metastatic Castration Resistant Prostate Cancer Patients
A randomized phase II study comparing the sequential use of abiraterone followed after progression by apalutamide with alternating cycles of abiraterone and apalutamide
Read the detailed description
This is an open-label, randomized phase II study to investigate the feasibility of alternating cycles of treatment with abiraterone plus prednisone and apalutamide compared to sequential treatment of abiratereone plus prednisone followed by apalutamide. 7 centers in Greece will participate in the study.
The study population consists of adult patients (over 18 years old) with histologically confirmed metastatic prostate adenocarcinoma who have disease progression - as defined by PCWG2 criteria - despite androgen deprivation therapy and who have not received prior therapy for their castration resistant disease.
The purpose of the study is to determine the progression free survival, feasibility and safety profile of the experimental arm compared to standard of care.
In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks of treatment consisting of 12 weeks of abiraterone acetate 1000mg orally qd and prednisone 5mg orally bid, followed by 12 weeks of apalutamide 240 mg per day. There will be no wash out period between cycles.
The comparative arm will be the standard regimen of abiraterone 1000mg orally qd plus prednisone 5mg orally bid until progression, followed thereafter by apalutamide 240mg orally qd until progression.
- Being tested
- Abiraterone, Apalutamide
- Keywords
- prostate cancer, abiraterone, apalutamide
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbirateroneDrug
Also called Zytiga
Abiraterone acetate 1000mg qD and prednisone 5mg bid administered orally
ApalutamideDrug
apalutamide 240mg qD orally
| Study group | Role | What they receive |
|---|---|---|
| Rotational | Experimental | Abiraterone acetate 1000mg qD and prednisone 5mg bid administered orally starting on Day 1 of Cycle 1 for 3 cycles, followed by apalutamide 240mg qD orally for 3 cycles. The duration of each cycle is 28 days Receives: Drug: Abiraterone; Drug: Apalutamide |
| Sequential | Active comparator | Abiraterone acetate 1000mg qD and prednisone 5mg bid administered orally starting on Day 1 of Cycle 1 until disease progression, followed by apalutamide 240mg qD orally until second disease progression. Receives: Drug: Abiraterone; Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression-free survival
time until radiographic progression as assessed by PCWG2 criteria
Measured: Estimated up to 24 months
Secondary outcomes (4)
Overall survival
time until death or lost to follow up
Measured: estimated up to 36 months
Time to cytotoxic therapy initiation
time until the beginning of chemotherapy
Measured: Estimated up to 24 months
Time until PSA progression
time until PSA progression as defined by PCWG2 criteria
Measured: Estimated up to 24 months
Incidence, nature and severity of AEs
recording of all AE/SAEs
Measured: Estimated up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startJan 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Delayed initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms, Castration-ResistantStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aristotelis Bamias, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173859
- Sponsor's protocol ID
- 70/3/14073
- Other IDs
- 2017-000443-41, 2017
- Acronym
- AERA
- Status last verified
- Nov 2020
- First submitted
- 28 May 2017
- Last updated
- 18 Nov 2020
- Results posted
- 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 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study to Investigate the Efficacy of Rotations Between Abiraterone Acetate and Apalutamide Versus Sequential Administration in Chemo-naïve Metastatic Castration Resistant Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03173859
- Acronym / sponsor ID
- AERA / 70/3/14073
- Keywords
- prostate cancer, abiraterone, apalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delayed initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Jun 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.
A randomized phase II study comparing the sequential use of abiraterone followed after progression by apalutamide with alternating cycles of abiraterone and apalutamide
Detailed description
This is an open-label, randomized phase II study to investigate the feasibility of alternating cycles of treatment with abiraterone plus prednisone and apalutamide compared to sequential treatment of abiratereone plus prednisone followed by apalutamide. 7 centers in Greece will participate in the study.
The study population consists of adult patients (over 18 years old) with histologically confirmed metastatic prostate adenocarcinoma who have disease progression - as defined by PCWG2 criteria - despite androgen deprivation therapy and who have not received prior therapy for their castration resistant disease.
The purpose of the study is to determine the progression free survival, feasibility and safety profile of the experimental arm compared to standard of care.
In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks of treatment consisting of 12 weeks of abiraterone acetate 1000mg orally qd and prednisone 5mg orally bid, followed by 12 weeks of apalutamide 240 mg per day. There will be no wash out period between cycles.
The comparative arm will be the standard regimen of abiraterone 1000mg orally qd plus prednisone 5mg orally bid until progression, followed thereafter by apalutamide 240mg orally qd until progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotational | Experimental | Drug: Abiraterone, Drug: ApalutamideAbiraterone acetate 1000mg qD and prednisone 5mg bid administered orally starting on Day 1 of Cycle 1 for 3 cycles, followed by apalutamide 240mg qD orally for 3 cycles. The duration of each cycle is 28 days |
| Sequential | Active comparator | Drug: Abiraterone, Drug: ApalutamideAbiraterone acetate 1000mg qD and prednisone 5mg bid administered orally starting on Day 1 of Cycle 1 until disease progression, followed by apalutamide 240mg qD orally until second 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 (15 listed)
- Signed Informed Consent Age >18 years Histologically confirmed metastatic or advanced prostate cancer adenocarcinoma that has received no treatment for the castration resistant disease and has progressed during treatment with complete androgen blockade (luteinizing hormone releasing hormone agonist or antagonist and an antiandrogen eg. Bicalutamide).
- Availability of a representative formalin-fixed, paraffin-embedded tumor specimen (FFPE) that enabled definitive diagnosis of prostate cancer.
- Two rising PSA levels >2ng/ml measured 1 week apart during or following the most recent prior therapy for prostate cancer (PCWG2 criteria) or radiographic evidence of disease progression in bone with or without biochemical disease progression on the basis of the PSA value.
- Ongoing androgen deprivation, with serum testosterone <50ng/dl ECOG performance status 0-1 at screening Adequate hematologic and organ function within 14 days before the first study treatment (hematologic parameters must be assessed >14 days after a prior transfusion, if any) as defined by
- Hemoglobin >9g/dl
Key exclusion criteria (5 listed)
- Small cell or neuroendocrine prostate carcinoma Inability or unwillingness to swallow pills Malabsorption syndrome or other condition that would interfere with enteral absorption Congenital long QT syndrome or QTc>480msec NYHA Class II to IV heart failure or LVEF <50% or ventricular arrhythmia requiring medication Previous therapy for prostate cancer with CYP17 inhibitors including ketoconazole or investigational agents (VMT-VT-464, Orteronel etc) or novel antiandrogens (enzalutamide of OMD-208) for more than 7 days Presence of visceral metastasis History of another invasive cancer within 3 years from screening, with the exception of fully treated cancers with a remote probability of recurrence Duration of previous Androgen Deprivation Therapy <12months Active infection requiring IV antibiotics
- unstable angina,
- myocardial infarction within 6 months from screening, or
- cerebrovascular accident within 6 months from screening Major surgical procedure within 4 weeks prior to initiation of study treatment Treatment with an investigational agent within 4 weeks prior to initiation of study treatment Unresolved, clinical significant toxicity from prior treatment Hypersensitivity reaction to the active pharmaceutical ingredient or any of the tablet components Any medical condition that restrain the patient to comply with study and follow-up procedures Inability to comply with study and follow up procedures
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 |
|---|---|---|
| AbirateroneAlso: ZytigaAbiraterone acetate 1000mg qD and prednisone 5mg bid administered orally | Drug | Rotational, Sequential |
| Apalutamideapalutamide 240mg qD orally | Drug | Rotational, Sequential |
Primary outcome
Radiographic progression-free survival
Time frame: Estimated up to 24 months
time until radiographic progression as assessed by PCWG2 criteria
4 secondary outcomes
Overall survival
Time frame: estimated up to 36 months
Time to cytotoxic therapy initiation
Time frame: Estimated up to 24 months
Time until PSA progression
Time frame: Estimated up to 24 months
Incidence, nature and severity of AEs
Time frame: Estimated up to 24 months
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 18 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone and Apalutamide in people with Prostatic Neoplasms, Castration-Resistant, run by University of Athens.
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 15 inclusion and 5 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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 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?
Radiographic progression-free survival (time frame: Estimated up to 24 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 18 Nov 2020.