Prostatic Cancer, Castration-ResistantPhase 2DaroAcTNCT04157088
Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)
A Phase 2 study testing Darolutamide (Nubeqa, BAY1841788) and Enzalutamide in people with Prostatic Cancer, Castration-Resistant, run by Bayer at 7 sites in United States.
Trial summary
Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Cancer, Castration-Resistant
- What is being tested?
- Darolutamide (Nubeqa, BAY1841788) and Enzalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Dec 2019to 8 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant must be 18 years of age inclusive or older at the time of signing the informed consent.
- Participants who have:
- Histologically or cytologically confirmed adenocarcinoma of prostate, CRPC (Castration-resistant prostate cancer) defined by disease progression despite ADT (Androgen deprivation therapy) and may present as either a confirmed rise in serum PSA (Prostate-specific antigen) levels (as defined by PCWG3 (Prostate Cancer Working Group)), the progression of pre-existing disease, and/or the appearance of new metastases. Metastatic and non-metastatic CRPC patients will be eligible.
- KPS (Karnofsky Performance Scale) performance status of ≥80
- Blood counts at screening: hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1500/μL, platelet count ≥100,000/μL
- Screening values of serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN), total bilirubin ≤1.5 × ULN, creatinine ≤2.0 × ULN
- Life expectancy of at least 1 year
- Sex: Male
Who cannot join
- Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis with abnormal renal function due to prostate cancer. Participants with visceral metastasis will be excluded.
- Past (within 6 months before the start of study intervention) or concurrent stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, and/or congestive heart failure (New York Heart Association Class III or IV)
- Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of the skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 3 years before the start of study intervention and from which the participant has been disease free
- Prior or concurrent central nervous system disease, such as epilepsy, Parkinson's disease, Alzheimer's disease, dementia, or multiple sclerosis
- Non-ambulatory participants who need a wheelchair. Other assistive devices (e.g., cane or walker) are permitted.
- Clinically significant limitations in cognitive function and/or physical function, such as >20 seconds in the TUG assessment
Show all 14Show fewer
- Prior treatment with any of the following:
- Second-generation AR inhibitors, such as enzalutamide, apalutamide, or Darolutamide
- Other investigational AR inhibitors
- Progression on abiraterone acetate and discontinuation within 6 months before signing the ICF for the study
- For mCRPC participants: any chemotherapy, and/or >2 prior lines of systemic anticancer treatment. Treatment with an LHRH agonist, LHRH antagonists, or orchidectomy is not counted as systemic treatment with regard to this exclusion criterion.
- Use of immunotherapy within 28 days before the start of study intervention
- Treatment with radiotherapy/radiopharmaceuticals within 12 weeks before the start of study intervention
- Previous participation in other clinical studies within 28 days before the start of study treatment or 5 half-lives of the investigational treatment of the previous study, whichever is longer Diagnostic assessments
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
MidLantic Urology - Bala Cynwyd
Bala-Cynwyd, Pennsylvania, 19004
Duke University Medical Center
Durham, North Carolina, 27710
Bon Secours St. Francis Hospital
Greenville, South Carolina, 29607
Carolina Urological Research Center
Myrtle Beach, South Carolina, 29579
Oregon Health and Science University
Portland, Maine, 97239
Montefiore Medical Center
The Bronx, New York, 10461
New Jersey Urology, LLC
Voorhees Township, New Jersey, 08043
About this study
Official title: A Randomized, Open-label, Multicenter, Phase 2b Study to Evaluate Physical Function, Including Balance and Daily Activity, in Participants With Castration-resistant Prostate Cancer Treated With Darolutamide or Enzalutamide
Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be asked to make some movements like rising from a chair, walking three meters, etc. Additionally, researchers also want to find out the survival of patients and if patients have fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.
- Conditions
- Prostatic Cancer, Castration-Resistant
- Being tested
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide (Nubeqa, BAY1841788)Drug
600mg, twice daily
EnzalutamideDrug
160mg, once daily
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with darolutamide | Experimental | Not described Receives: Drug: Darolutamide (Nubeqa, BAY1841788) |
| Participants treated with enzalutamide | Experimental | Not described Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Worsening in TUG Time During the 24- Week Period.
TUG: Timed Up \& Go. Worsening is defined as an increase of at least 1 second in TUG time from baseline. (The minimum clinically important difference [MCID] in TUG time is 1 second
Measured: Up to 24 weeks
Secondary outcomes (19)
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
Worsening was defined as an increase of at least 1 second in TUG time from baseline.
Improved was defined at least 1 second decrease from baseline. Stable was defined as change from baseline between less than 1 second increase and less than 1 second decrease.
Measured: At 12 week, 24 week and 52 week.
Time to Worsening (Increase of at Least 1 Second) in TUG Time
At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.
Measured: From randomization to the first date a participant had a worsening.
Number of Participants With a Worsening in SPPB Total Score at 12 and 24 Weeks and During the 24 Weeks and 52 Weeks From Baseline.
The SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance)
Measured: At 12 and 24 weeks and during the 24 weeks and 52 weeks from baseline
Mean Change From Baseline in Daily Physical Activity as Assessed by CPM, at 12 and 24 Weeks, and During the 24 Weeks and 52 Weeks From Baseline.
Participants required at least 2 valid days to be included in the analysis at each visit. 'Valid' is defined as at least 10 awake wear hours. CPM for each valid day is defined as 'awake wear-filtered total vector magnitude counts' divided by 'awake wear minutes''. A participant's CPM at each visit is the average of daily CPM.
Measured: At 12 week, 24 week and 52 week
Mean Change From Baseline in Accelerometer-assessed Proportion of Time Spent in Light to Vigorous Physical Activity Based on a Threshold of >100 Activity Counts Per Minute.
At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.
Measured: At 12, 24, and 52 weeks for the randomization phase
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.
The HVLT-R is a learning and memory test, in which the participant is asked to learn and recall a list of 12 words over three trials. The HVLT-R TR (total score) score ranges from 0 to 36, where higher scores indicated greater verbal learning and recall. The HVLT-R DR (delayed recall) score ranges from 0 to 12, where higher scores indicated greater verbal learning and recall. The HVLT-R RECOG (Delayed Recognition) score ranges from -12 to 12, where higher scores indicated better performance.
Measured: During the 24 weeks and 52 weeks from baseline.
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by TMT.
TMT Part A (TMTA) is timed up to a maximum of 3 minutes, and TMT Part B (TMTB) is timed up to a maximum of 5 minutes. The lower score indicated the better performance.
Measured: During the 24 weeks and 52 weeks from baseline.
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by COWA.
The COWA test assessed lexical fluency. Given a specific letter of the alphabet, participants were required to produce as many words as possible that begin with that letter. There were two alternate forms of the COWA, each with three unique letter exemplars. The lowest possible score is zero, meaning no words could be produced. There is no limit to the higher end of the scale given that participants can produce as many words as possible for each of the three letters. Higher scores indicate greater word retrieval and better cognitive function.
Measured: During the 24 weeks and 52 weeks from baseline.
Number of Participants With a Decline Using a Selected Domain of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog).
FACT-Cog with a range of 0-28 points, higher score is better. Decline was defined as a decrease of >10 points during the 24 weeks and 52 weeks from baseline.
Measured: During the 24 weeks and 52 weeks from baseline.
Number of Participants With a Worsening of Fatigue During the 24 Weeks and 52 Weeks.
At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.
Measured: Up to 52 weeks in randomization phase.
Number of Participants With an Increase of at Least 1 Point in Fatigue Interference by 24 Weeks and 52 Weeks From Baseline (Based on Items 4A-F of the BFI)
Fatigue Interference decline is defined as an increase of at least 1 point in any Fatigue Interference from baseline.
BFI: Brief Fatigue Inventory. BFI is a 5 minute self-assessment tool that identifies fatigue in cancer participants over a 24-hour period.
Measured: At 24 weeks and 52 weeks
Number of Participants With a Worsening in Scores in the PHQ-9 During the 24 Weeks and 52 Weeks From Baseline.
At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.
Measured: Up to 52 weeks in randomization phase
Number of Participants With Treatment Emergent AEs, SAEs, and AEs Leading to Study Intervention Discontinuation
Treatment-Emergent Adverse Events (TEAEs) were defined as any events arising or worsening after the first dose of study drug until 30 days after last dose.
SAEs: Serious adverse events
Measured: Up to 52 weeks
Number of Participants With AEs of Interest, Including Falls, Fractures, and Hypothyroidism
AEs of interest were followed up regardless of causality or relationship to study intervention.
Measured: Up to 52 weeks
Time to Deterioration of Karnofsky Performance Scale (KPS) Defined as at Least a 10 Point Decline From Baseline.
At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.
Measured: From randomization to the first date the participant had had a decline in KPS of at least 10 points.
Number of Participants With Treatment Exposure of the Study Intervention Including Time on Treatment
A total of 30 participants received treatment with darolutamide 600 mg twice daily in the lead-in phase of the study, comprising the safety evaluable population.
No participant received either darolutamide or enzalutamide in the randomized phase of the study as the study was terminated prematurely prior to the initiation of the randomized phase of the study.
Measured: Up to 52 weeks
Number of Participants With Dose Reductions of Study Intervention
At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.
Measured: Up to 52 weeks in randomization phase
Time to Prostate-specific Antigen (PSA) Progression (as Per Prostate Cancer Working Group [PCWG3] Criteria)
At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.
Measured: From randomization to the time when the criteria for PSA progression (according to PCWG3) was met, up to 52 weeks.
Survival Status
At the end of the lead-in phase, the overall feasibility of the study execution was assessed and decided not to proceed with the randomized phase. Therefore, data on this outcome which needed to be collected in the randomized phase was unavailable.
Measured: Up to 52 weeks in randomization phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start17 Dec 2019
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Why it stopped: The results of the lead-in phase did not fulfill the criteria set for moving into the randomized phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic Cancer, Castration-ResistantStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157088
- Sponsor's protocol ID
- 20609
- Acronym
- DaroAcT
- Status last verified
- Jul 2023
- First submitted
- 21 Oct 2019
- Last updated
- 4 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase 2b Study to Evaluate Physical Function, Including Balance and Daily Activity, in Participants With Castration-resistant Prostate Cancer Treated With Darolutamide or Enzalutamide
- ClinicalTrials.gov ID
- NCT04157088
- Acronym / sponsor ID
- DaroAcT / 20609
- Conditions
- Prostatic Cancer, Castration-Resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The results of the lead-in phase did not fulfill the criteria set for moving into the randomized phase
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Posted 4 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be asked to make some movements like rising from a chair, walking three meters, etc. Additionally, researchers also want to find out the survival of patients and if patients have fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants treated with darolutamide | Experimental | Drug: Darolutamide (Nubeqa, BAY1841788) |
| Participants treated with enzalutamide | Experimental | Drug: Enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must be 18 years of age inclusive or older at the time of signing the informed consent.
- Participants who have:
- Sex: Male
Key exclusion criteria (14 listed)
- Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis with abnormal renal function due to prostate cancer. Participants with visceral metastasis will be excluded.
- Past (within 6 months before the start of study intervention) or concurrent stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, and/or congestive heart failure (New York Heart Association Class III or IV)
- Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of the skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 3 years before the start of study intervention and from which the participant has been disease free
- Prior or concurrent central nervous system disease, such as epilepsy, Parkinson's disease, Alzheimer's disease, dementia, or multiple sclerosis
- Non-ambulatory participants who need a wheelchair. Other assistive devices (e.g., cane or walker) are permitted.
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 |
|---|---|---|
| Darolutamide (Nubeqa, BAY1841788)600mg, twice daily | Drug | Participants treated with darolutamide |
| Enzalutamide160mg, once daily | Drug | Participants treated with enzalutamide |
Primary outcome
Number of Participants With a Worsening in TUG Time During the 24- Week Period.
Time frame: Up to 24 weeks
TUG: Timed Up \& Go. Worsening is defined as an increase of at least 1 second in TUG time from baseline. (The minimum clinically important difference [MCID] in TUG time is 1 second
19 secondary outcomes
Number of Participants With an Increase of at Least 1 Second in TUG Time at 12 and 24 Weeks and During the 52 Weeks.
Time frame: At 12 week, 24 week and 52 week.
Time to Worsening (Increase of at Least 1 Second) in TUG Time
Time frame: From randomization to the first date a participant had a worsening.
Number of Participants With a Worsening in SPPB Total Score at 12 and 24 Weeks and During the 24 Weeks and 52 Weeks From Baseline.
Time frame: At 12 and 24 weeks and during the 24 weeks and 52 weeks from baseline
Mean Change From Baseline in Daily Physical Activity as Assessed by CPM, at 12 and 24 Weeks, and During the 24 Weeks and 52 Weeks From Baseline.
Time frame: At 12 week, 24 week and 52 week
Mean Change From Baseline in Accelerometer-assessed Proportion of Time Spent in Light to Vigorous Physical Activity Based on a Threshold of >100 Activity Counts Per Minute.
Time frame: At 12, 24, and 52 weeks for the randomization phase
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by HVLT-R.
Time frame: During the 24 weeks and 52 weeks from baseline.
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by TMT.
Time frame: During the 24 weeks and 52 weeks from baseline.
Number of Participants With a Decline in Cognitive Function During the 24 Weeks and 52 Weeks From Baseline, as Assessed by COWA.
Time frame: During the 24 weeks and 52 weeks from baseline.
Number of Participants With a Decline Using a Selected Domain of Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog).
Time frame: During the 24 weeks and 52 weeks from baseline.
Number of Participants With a Worsening of Fatigue During the 24 Weeks and 52 Weeks.
Time frame: Up to 52 weeks in randomization phase.
Number of Participants With an Increase of at Least 1 Point in Fatigue Interference by 24 Weeks and 52 Weeks From Baseline (Based on Items 4A-F of the BFI)
Time frame: At 24 weeks and 52 weeks
Number of Participants With a Worsening in Scores in the PHQ-9 During the 24 Weeks and 52 Weeks From Baseline.
Time frame: Up to 52 weeks in randomization phase
Number of Participants With Treatment Emergent AEs, SAEs, and AEs Leading to Study Intervention Discontinuation
Time frame: Up to 52 weeks
Number of Participants With AEs of Interest, Including Falls, Fractures, and Hypothyroidism
Time frame: Up to 52 weeks
Time to Deterioration of Karnofsky Performance Scale (KPS) Defined as at Least a 10 Point Decline From Baseline.
Time frame: From randomization to the first date the participant had had a decline in KPS of at least 10 points.
Number of Participants With Treatment Exposure of the Study Intervention Including Time on Treatment
Time frame: Up to 52 weeks
Number of Participants With Dose Reductions of Study Intervention
Time frame: Up to 52 weeks in randomization phase
Time to Prostate-specific Antigen (PSA) Progression (as Per Prostate Cancer Working Group [PCWG3] Criteria)
Time frame: From randomization to the time when the criteria for PSA progression (according to PCWG3) was met, up to 52 weeks.
Survival Status
Time frame: Up to 52 weeks in randomization phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darolutamide (Nubeqa, BAY1841788) and Enzalutamide in people with Prostatic Cancer, Castration-Resistant, run by Bayer at 7 sites in United States.
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 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2023. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Worsening in TUG Time During the 24- Week Period. (time frame: Up to 24 weeks). 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 4 Aug 2023.