Metastatic Prostate CancerPhase 3CARENCT05771896
Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC
A Phase 3 study testing Darolutamide and Radium-223 in people with Metastatic Prostate Cancer, run by GenesisCare USA.
Trial summary
The goal of this clinical trial is to compare the combination of Darolutamide with Radium-223 or placebo and the effects on radiological progression-free survival for patients with Metastatic Castration-Sensitive Prostrate Cancer (mCSPC) The main questions it aims to answer are: Radiological progression-free survival… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Darolutamide and Radium-223
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Apr 2029
- 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 is able and willing to provide informed consent.
- Metastatic castration-sensitive prostate cancer (mCSPC) at screening with histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- Men ≥ 18 years.
- ECOG performance status of 0, 1 or 2 at screening.
- Metastatic to bone with ≥ 2 bone metastases (area of increased uptake on 99mTc methylene diphosphonate bone scan); equivocal lesions on the bone scan must be confirmed by standard X-ray, CT, or MRI.
- Ongoing ADT by Investigator's choice with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or bilateral orchiectomy for less than 120 days prior to randomization. ADT treatment should be on a stable dose without interruptions of at least 4 weeks prior to first dose of blinded IP.
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- On bone health agents with at least one dose of BHA prior to first dose of blinded IP.
- Adequate bone marrow and organ function as defined by:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L (participant must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at Screening)
- Serum creatinine ≤2 x upper limit of normal ULN
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 x upper limit of normal (ULN)
- Total bilirubin < 1.5 x ULN, unless the participant a diagnosis of Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin; in participants with Gilbert's, the total bilirubin should be < 3 x ULN and the elevation should be seen in the unconjugated or indirect bilirubin measurement)
- Albumin ≥ 2.5 g/dL
- Fertile male participants, defined as all males physiologically capable of conceiving offspring with female partners of child-bearing potential, must be willing to use condoms plus spermicidal agent during the study treatment period and for 6 months after the last dose of blinded IP, and not father a child or donate sperm during this period.
- No known contraindication to any study treatment (darolutamide, radium-223, and/or Investigator's choice ADT).
Who cannot join
- Pathological finding consistent with small cell carcinoma of the prostate.
- Prior treatment for mCSPC [excluding ADT ≤120 days and first-generation ARI (bicalutamide, nilutamide or flutamide) for ≤120 days when initiating ADT], with the exception of Metastases Directed Therapy (MDT) with EBRT/SBRT (at least 2 bone metastases must be untreated). Prior treatment for localized prostate cancer is allowed (all treatments must have been completed ≥ 1 year prior to randomization)
- Treatment for mCSPC with ADT starting >120 days prior to randomization.
- Treatment for mCSPC with first generation ARI (bicalutamide, nilutamide or flutamide) starting >120 days prior to randomization.
- Prior hemi-body or whole-body external radiotherapy.
- Other types of prior external radiotherapy and brachytherapies are allowed, if more than 28 days prior to randomization.
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- Prior therapy with radionuclides (e.g., including but not limited to radium-223, strontium-89, samarium-153), including prior therapy with investigational radionuclides (e.g., including but not limited to iodine-131, rhenium-186, rhenium- 188, thorium- 277, actinium-225 and lutetium-177).
- Prior treatment with:
- Second-generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors.
- Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer.
- Chemotherapy including docetaxel or immunotherapy for prostate cancer.
- Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization.
- Current involvement in any drug or device trial involving investigational agent or medical device within the last 28 days prior to randomization.
- Any prior investigational agent for nmCSPC/mCSPC.
- Known hypersensitivity to compounds related to darolutamide, or radium-223, or to CT and/or MRI contrast media.
- A blood transfusion ≤ 28 days prior to randomization.
- Major surgical procedures ≤ 28 days or minor surgical procedures ≤7 days prior to randomization. No waiting period is required following port-a-cath placement.
- Superscan on 99mTc methylene diphosphonate bone scan.
About this study
Official title: A Phase III Randomized Study Comparing the Combination of Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)
The goal of this clinical trial is to compare the combination of Darolutamide with Radium-223 or placebo and the effects on radiological progression-free survival for patients with Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)
The main questions it aims to answer are:
- Radiological progression-free survival (rPFS) in mCSPC
- Overall Survival (OS)
- Symptomatic skeletal event-free survival (SSE-FS)
- Initiation of subsequent antineoplastic therapy
- Safety
Participants will have visits at baseline, treatment is once a month for up to 6 months, and long term follow up will continue until the participant dies, withdraws consent, and/or study is terminated.
Read the detailed description
A novel treatment strategy combining darolutamide and radium-223 is considered for subjects with mCSPC. Response to treatment is monitored every 12 weeks using a continuous measurement. The main scientific question concerns the comparison of radium-223 to placebo and is best addressed by a randomized clinical trial. Use of placebo in this study is considered ethical, as provision is made for subjects to discontinue their treatment and switch to radium-223 due to lack of efficacy on unblinding where it influences current treatment decisions. Switch to rescue medication is an intercurrent event, after which it is still possible to collect the variable measurements as described in sections on study endpoints below. This is also the case after other intercurrent events such as discontinuation of radium-223 treatment due to an adverse event, but not for intercurrent events such as death unrelated to study IP or disease, subject loss to follow-up, or subject withdrawal from all study treatments and procedures.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Darolutamide, Radium-223
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarolutamideDrug
Also called Nubeqa
Participants will continue treatment with darolutamide until radiological progression, withdrawal, death, termination, or study completion.
The maximum time for darolutamide dose interruption period is 28 consecutive days beyond scheduled dose (>56 days between cycles). Any participant requiring dose interruption >28 consecutive days beyond the scheduled dose may restart treatment with darolutamide if clinical benefit is anticipated and after discussion with and approval from the study Medical Monitor.
Until primary endpoint is reached, participants are not allowed to switch ARPI (Abiraterone, Apalutamide or Enzalutamide) during the study. Switching to other ARPI following radiographic progression should be considered a subsequent life prolonging therapy and documented accordingly.
Radium-223Drug
Also called Xofigo
Radium-223 should be given for 6 cycles, administered IV on Day 1 of each cycle or until radiological progression, withdrawal, death, termination, or study completion. The placebo will be administered in precisely the same fashion as the active drug.
Subsequent cycles 2-6 should be scheduled to occur every 28 ± 7 days following the previous cycle, but dosing may be delayed up to 28 days per cycle (maximum 56 days between cycles). Any participant requiring dose interruption >28 consecutive days (>56 days between cycles) may restart treatment with radium-223/placebo if clinical benefit is anticipated and after discussion with the Medical Monitor. Participants will continue with darolutamide irrespective of Radium-223 administration.
Upon radiological progression, further treatments are decided by the site investigator according to standard local practice.
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide with Radium-223 | Experimental | Darolutamide:
Dosage:600mg Route: By mouth (PO) Frequency: Twice a day, throughout the duration of the study
Radium-223:
Dosage: 55 kBq/kg body weight or 1.49 microcurie/kg body weight Route: IV Frequency: Every 28+/-7 days, a maximum of 6 cycles Receives: Drug: Darolutamide; Drug: Radium-223 |
| Darolutamide with Placebo | Placebo comparator | Darolutamide:
Dosage:600mg Route: By mouth (PO) Frequency: Twice a day, throughout the duration of the study
Placebo:
Dosage: 55 kBq/kg body weight or 1.49 microcurie/kg body weight Route: IV Frequency: Every 28+/-7 days, a maximum of 6 cycles Receives: Drug: Darolutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological progression-free survival (rPFS) in mCSPC patients
The primary objective of this study is to compare the radiological progression-free survival (rPFS) in mCSPC patients treated with darolutamide plus radium-223 versus darolutamide plus placebo. The primary endpoint is radiological progression-free survival rPFS, defined as time to first occurrence of 99mTc MDP+ bone scan progression per PCWG3 criteria, and/or soft tissue progression by CT/MRI per PCWG3 modifications to RECIST 1.1 criteria, or death from any cause. Randomization will be stratified by ECOG performance status 0 vs 1-2, and metastatic disease status, specifically low volume (<4 bone lesions) versus high volume (≥4 bone lesions).
Measured: First occurrence bone scan progression and/or soft tissue progression per #RECIST 1.1 criteria, participant dies, withdraws consent and/or study is terminated, whichever comes first.
Secondary outcomes (3)
Overall Survival (OS) & Symptomatic Skeletal Event-Free Survival (SSE-FS)
Overall survival and SSE-FS will be compared between the two arms using a stratified log-rank test, HR (Darolutamide + radium-223 dichloride / Darolutamide + placebo) with 95% CI. Kaplan-Meier estimates and plots for both treatment arms will be produced to accompany these analyses. The median, 25th and 75th percentiles and event free rates at different timepoints with associated 95% CI will be generated.
SSE-FS as defined as the time from randomization until any one of the following:
- the first use of external-beam radiation therapy to relieve skeletal tumor-related symptoms,
- the occurrence of new symptomatic pathologic bone fractures,
- the occurrence of new symptomatic spinal cord compression,
- a tumor-related orthopedic surgical intervention, or
- death.
Measured: Randomization until death.
Initiation of Subsequent Antineoplastic Therapy
Time to initiation of subsequent antineoplastic therapy will be compared considering death as a competing risk. Treatment arms will be compared with stratified competing risk HR (Darolutamide + radium-223 dichloride / Darolutamide + placebo) with 95% CI. Event rates will be estimated by cumulative incidence.
Measured: Randomization to initiation of first subsequent antineoplastic therapy for prostrate cancer.
Safety of the combination of radium-223 and Darolutamide
Safety of the combination of radium-223 and Darolutamide will be assessed by the incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) per Common Toxicity Criteria for Adverse Events (CTCAE) v5.0. Exposure-adjusted incidence rates (EAIR) may be provided.
Measured: First treatment dose until last dose + 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionApr 2029 (estimated)
Why it stopped: Bayer withdrew their support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenesisCare USA
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771896
- Sponsor's protocol ID
- 00019_CARE
- Acronym
- CARE
- Status last verified
- Sep 2023
- First submitted
- 6 Feb 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study Comparing the Combination of Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)
- ClinicalTrials.gov ID
- NCT05771896
- Acronym / sponsor ID
- CARE / 00019_CARE
- Conditions
- Metastatic Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Bayer withdrew their support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GenesisCare USAUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 16 Mar 2023 (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.
The goal of this clinical trial is to compare the combination of Darolutamide with Radium-223 or placebo and the effects on radiological progression-free survival for patients with Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)
The main questions it aims to answer are:
- Radiological progression-free survival (rPFS) in mCSPC
- Overall Survival (OS)
- Symptomatic skeletal event-free survival (SSE-FS)
- Initiation of subsequent antineoplastic therapy
- Safety
Participants will have visits at baseline, treatment is once a month for up to 6 months, and long term follow up will continue until the participant dies, withdraws consent, and/or study is terminated.
Detailed description
A novel treatment strategy combining darolutamide and radium-223 is considered for subjects with mCSPC. Response to treatment is monitored every 12 weeks using a continuous measurement. The main scientific question concerns the comparison of radium-223 to placebo and is best addressed by a randomized clinical trial. Use of placebo in this study is considered ethical, as provision is made for subjects to discontinue their treatment and switch to radium-223 due to lack of efficacy on unblinding where it influences current treatment decisions. Switch to rescue medication is an intercurrent event, after which it is still possible to collect the variable measurements as described in sections on study endpoints below. This is also the case after other intercurrent events such as discontinuation of radium-223 treatment due to an adverse event, but not for intercurrent events such as death unrelated to study IP or disease, subject loss to follow-up, or subject withdrawal from all study treatments and procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darolutamide with Radium-223 | Experimental | Drug: Darolutamide, Drug: Radium-223Darolutamide: Dosage:600mg Route: By mouth (PO) Frequency: Twice a day, throughout the duration of the study Radium-223: Dosage: 55 kBq/kg body weight or 1.49 microcurie/kg body weight Route: IV Frequency: Every 28+/-7 days, a maximum of 6 cycles |
| Darolutamide with Placebo | Placebo comparator | Drug: DarolutamideDarolutamide: Dosage:600mg Route: By mouth (PO) Frequency: Twice a day, throughout the duration of the study Placebo: Dosage: 55 kBq/kg body weight or 1.49 microcurie/kg body weight Route: IV Frequency: Every 28+/-7 days, a maximum of 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient is able and willing to provide informed consent.
- Metastatic castration-sensitive prostate cancer (mCSPC) at screening with histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- Men ≥ 18 years.
- ECOG performance status of 0, 1 or 2 at screening.
- Metastatic to bone with ≥ 2 bone metastases (area of increased uptake on 99mTc methylene diphosphonate bone scan); equivocal lesions on the bone scan must be confirmed by standard X-ray, CT, or MRI.
Key exclusion criteria (18 listed)
- Pathological finding consistent with small cell carcinoma of the prostate.
- Prior treatment for mCSPC [excluding ADT ≤120 days and first-generation ARI (bicalutamide, nilutamide or flutamide) for ≤120 days when initiating ADT], with the exception of Metastases Directed Therapy (MDT) with EBRT/SBRT (at least 2 bone metastases must be untreated). Prior treatment for localized prostate cancer is allowed (all treatments must have been completed ≥ 1 year prior to randomization)
- Treatment for mCSPC with ADT starting >120 days prior to randomization.
- Treatment for mCSPC with first generation ARI (bicalutamide, nilutamide or flutamide) starting >120 days prior to randomization.
- Prior hemi-body or whole-body external radiotherapy.
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 |
|---|---|---|
| DarolutamideAlso: NubeqaParticipants will continue treatment with darolutamide until radiological progression, withdrawal, death, termination, or study completion. The maximum time for darolutamide dose interruption period is 28 consecutive days beyond scheduled dose (>56 days between cycles). Any participant requiring dose interruption >28 consecutive days beyond the scheduled dose may restart treatment with darolutamide if clinical benefit is anticipated and after discussion with and approval from the study Medical Monitor. Until primary endpoint is reached, participants are not allowed to switch ARPI (Abiraterone, Apalutamide or Enzalutamide) during the study. Switching to other ARPI following radiographic progression should be considered a subsequent life prolonging therapy and documented accordingly. | Drug | Darolutamide with Placebo, Darolutamide with Radium-223 |
| Radium-223Also: XofigoRadium-223 should be given for 6 cycles, administered IV on Day 1 of each cycle or until radiological progression, withdrawal, death, termination, or study completion. The placebo will be administered in precisely the same fashion as the active drug. Subsequent cycles 2-6 should be scheduled to occur every 28 ± 7 days following the previous cycle, but dosing may be delayed up to 28 days per cycle (maximum 56 days between cycles). Any participant requiring dose interruption >28 consecutive days (>56 days between cycles) may restart treatment with radium-223/placebo if clinical benefit is anticipated and after discussion with the Medical Monitor. Participants will continue with darolutamide irrespective of Radium-223 administration. Upon radiological progression, further treatments are decided by the site investigator according to standard local practice. | Drug | Darolutamide with Radium-223 |
Primary outcome
Radiological progression-free survival (rPFS) in mCSPC patients
Time frame: First occurrence bone scan progression and/or soft tissue progression per #RECIST 1.1 criteria, participant dies, withdraws consent and/or study is terminated, whichever comes first.
The primary objective of this study is to compare the radiological progression-free survival (rPFS) in mCSPC patients treated with darolutamide plus radium-223 versus darolutamide plus placebo. The primary endpoint is radiological progression-free survival rPFS, defined as time to first occurrence of 99mTc MDP+ bone scan progression per PCWG3 criteria, and/or soft tissue progression by CT/MRI per PCWG3 modifications to RECIST 1.1 criteria, or death from any cause. Randomization will be stratified by ECOG performance status 0 vs 1-2, and metastatic disease status, specifically low volume (<4 bone lesions) versus high volume (≥4 bone lesions).
3 secondary outcomes
Overall Survival (OS) & Symptomatic Skeletal Event-Free Survival (SSE-FS)
Time frame: Randomization until death.
Initiation of Subsequent Antineoplastic Therapy
Time frame: Randomization to initiation of first subsequent antineoplastic therapy for prostrate cancer.
Safety of the combination of radium-223 and Darolutamide
Time frame: First treatment dose until last dose + 30 Days
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 14 Sep 2023.
- 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 3 study testing Darolutamide and Radium-223 in people with Metastatic Prostate Cancer, run by GenesisCare USA.
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 17 inclusion and 18 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 14 Sep 2023. 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. 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 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?
Radiological progression-free survival (rPFS) in mCSPC patients (time frame: First occurrence bone scan progression and/or soft tissue progression per #RECIST 1.1 criteria, participant dies, withdraws consent and/or study is terminated, whichever comes first.). 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 14 Sep 2023.