Metastatic Castration-resistant Prostate CancerPhase 3ESCALATENCT04237584
A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients
A Phase 3 study testing Enzalutamide during Lead-in Period, Lead-in Enzalutamide followed by Radium-223/Enzalutamide and Darolutamide during Lead-in Period in people with Metastatic Castration-resistant Prostate Cancer, run by MANA RBM at 1 site in United States.
Trial summary
This is a randomized, multi-center, double-blind, Phase III study of radium-223 plus enzalutamide or darolutamide compared to enzalutamide or darolutamide treatment plus placebo. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Enzalutamide during Lead-in Period, Lead-in Enzalutamide followed by Radium-223/Enzalutamide and Darolutamide during Lead-in Period
- 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
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2020to 7 Mar 2022
- Phase
- Phase 3
- 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
- Able and willing to provide informed consent.
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- Men ≥ 18 years.
- ECOG performance status of 0 or 1 at screening.
- Metastatic to bone with ≥ 2 bone metastases (area of increased uptake on 99mTc bone scan); equivocal lesions on the bone scan must be confirmed by standard X-ray, CT, or MRI.
- Patients must have progressive metastatic castration-resistant prostate cancer (mCRPC) at screening and on androgen deprivation therapy (ADT) as evidenced by either:
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- For patients who manifest disease progression solely as a rising prostate-specific antigen (PSA) level - documentation of a sequence of two rising PSA values at a minimum of 1-week apart with the Screening value ≥1 ng/ml (see Appendix D);
- For patients with disease progression manifested in the bone, irrespective of progression by rising PSA - defined by the appearance of 2 or more new skeletal lesions demonstrated by 99Tc bone imaging. Ambiguous results should be confirmed by other imaging modalities than bone scan and x-ray (e.g.: CT-scan or MRI).
- For patients with disease progression manifested at nodal sites, irrespective of progression by rising PSA - progression defined per RECIST 1.1.
- Ongoing ADT with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or bilateral orchiectomy.
- Use of bone health agents (denosumab or zoledronic acid or other bisphosphonates) starting any time prior to R1 unless contraindicated or considered not in the best interest of the patient. A waiver must be approved by the medical monitor if bone health agents cannot be used. Bone health agents should be continued throughout both RT1 and RT2 treatment periods.
- Adequate bone marrow and organ function as defined by:
- Hemoglobin ≥ 10.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Serum creatinine ≤ 1.95 mg/dL
- Estimated creatinine clearance >/= 30 mL/min by Cockroft-Gault calculation
- Alanine aminotransferase (ALT) ≤ 175 U/L
- Aspartate aminotransferase (AST) ≤ 100 U/L
- Total bilirubin ≤ 1.8 mg/dL (unless the patient a diagnosis of Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin; in patients with Gilbert's, the total bilirubin should be less than 6 mg/dL if patient has Gilbert's and the elevation should be seen in the unconjugated or indirect bilirubin measurement)
- LDH ≤ 224 U/L at screening.
- Albumin ≥ 2.5 g/dL
- Fertile male patients, 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 study drug, and not father a child or donate sperm during this period.
- The treating site investigator deems RT1 (Enzalutamide or Darolutamide) treatment safe and feasible.
- Subjects must meet the remaining inclusion criteria in order to be qualified for the second randomization (R2). Only subjects that complete the initial 12 weeks of run-in RT1 should be evaluated. Prior inclusion criteria do not need to be re-evaluated:
- Patients must have a documented ≥ 30% decline of PSA at any time during the 12 weeks of RT1.
- Patients must have no evidence of visceral metastatic disease at the time of RT2 randomization
- Ongoing treatment with RT1 and bone health agents at time of RT2 randomization.
- The treating site investigator deems RT2 (Ra-223 dichloride) treatment safe and feasible.
Who cannot join
- Pathological finding consistent with small cell carcinoma of the prostate.
- Prior chemotherapy for CRPC. Prior docetaxel for hormone-sensitive disease is permitted under the following conditions: started within 3 months of ADT initiation, given for a maximum of 6 cycles and progression occurred > 6 months after the last dose of docetaxel.
- Prior treatment for mCRPC or CRPC. However, the following therapies are permitted and not exclusionary: Sipuleucel-T, 5-alpha-reductase inhibitors, estrogens, or older antiandrogens (such as flutamide, bicalutamide, or nilutamide).
- Prior treatment for more than 2 months with CYP17 inhibitors (e.g. abiraterone or orteronel).
- Prior treatment for more than 2 months with agents inhibiting androgen receptor signaling (e.g. enzalutamide, apalutamide, or darolutamide).
- Prior hemibody or whole-body external radiotherapy. Other types of prior external radiotherapy and brachytherapies are allowed.
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- Prior therapy with radionuclides (e.g., radium-223, strontium-89, samarium-153, rhenium-186, rhenium-188, actinium-225 and lutetium-177).
- Current involvement in any drug or device trial involving investigational agent or medical device within the last 28 days prior to R1.
- In general, any prior investigational agent for nmCRPC/mCRPC; however, may be reviewed by medical monitor/PIs for waiver consideration, on a case-by-case basis.
- Hypersensitivity to compounds related to enzalutamide, darolutamide, or Ra-223.
- A blood transfusion ≤ 28 days prior to R1.
- Major surgical procedures ≤ 28 days or minor surgical procedures ≤7 days prior to R1. No waiting period is required following port-a-cath placement.
- Patients with visceral metastases, clinical evidence of central nervous system metastases, or leptomeningeal tumor spread as demonstrated via CT/MRI of chest, abdomen, pelvis, and CNS (if needed). CT/MRI of the CNS only performed if suspicion of CNS metastases or leptomeningeal tumor spread. Nodules < 1 cm alone will not be considered visceral metastases. Renal masses < 3 cm will not be considered exclusionary.
- Serious active infection at the time of screening or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- Presence of other active cancers, or history of treatment for invasive cancer ≤2 years of R1. Patients with Stage I/II cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) and superficial bladder cancer are eligible, as are patients with history of non-melanoma skin cancer.
- Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide With Radium-223 vs Enzalutamide or Darolutamide With Placebo and the Effect Upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients
This is a randomized, multi-center, double-blind, Phase III study of radium-223 plus enzalutamide or darolutamide compared to enzalutamide or darolutamide treatment plus placebo.
Read the detailed description
The hypothesis investigators will test in this study is whether layering radium-223 following 16 weeks of enzalutamide or darolutamide exposure in patients demonstrating a biochemical response improves disease outcomes. By adding radium-223 following a potential bone flare phenomenon [after first 12-14 weeks of therapy with an androgen receptor blocker (ARB)], including patients expected to have durable response to systemic therapy, and mandating the use of bone protective agents during treatment, the investigators aim to demonstrate an optimal time to add radium-223 in the mCRPC landscape.
- Being tested
- Enzalutamide during Lead-in Period, Lead-in Enzalutamide followed by Radium-223/Enzalutamide, Lead-in Enzalutamide followed by Placebo/Enzalutamide, Darolutamide during Lead-in Period, Lead-in Darolutamide followed by Radium-223/Darolutamide
- Keywords
- mCRPC, ARB, Radiopharmaceutical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide during Lead-in PeriodDrug
Also called Xtandi
Participants will receive 12 weeks open-label lead-in ARB (enzalutamide) that will continue after double-blind randomization to radium-223 or placebo.
Lead-in Enzalutamide followed by Radium-223/EnzalutamideDrug
Also called Xofigo, Xtandi
After a 12-week lead-in period of open-label enzalutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label enzalutamide.
Lead-in Enzalutamide followed by Placebo/EnzalutamideDrug
Also called Placebo, Xtandi
After a 12-week lead-in period of open-label enzalutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label enzalutamide.
Darolutamide during Lead-in PeriodDrug
Also called Nubeqa
Participants will receive 12 weeks open-label lead-in darolutamide that will continue after double-blind randomization to radium-223 or placebo.
Lead-in Darolutamide followed by Radium-223/DarolutamideDrug
Also called Xofigo, Nubeqa
After a 12-week lead-in period of open-label darolutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label darolutamide.
Lead-in Darolutamide followed by Placebo/DarolutamideDrug
Also called Placebo, Nubeqa
After a 12-week lead-in period of open-label darolutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label darolutamide.
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide during Lead-in Period | Other | Randomized, open-label lead-in ARB (enzalutamide tablets, 160 mg PO QD) for 12 weeks. Receives: Drug: Enzalutamide during Lead-in Period |
| Lead-in Enzalutamide followed by Radium-223/Enzalutamide | Active comparator | Randomized, open-label lead-in ARB (enzalutamide) for 12 weeks followed by randomized, double-blind Radium-223 IV at 55 kBq/kg IV up to 6 cycles (at 4 week intervals) with continued randomized open-label enzalutamide. Receives: Drug: Lead-in Enzalutamide followed by Radium-223/Enzalutamide |
| Lead-in Enzalutamide followed by Placebo/Enzalutamide | Placebo comparator | Randomized, open-label lead-in ARB (enzalutamide) for 12 weeks followed by randomized, double-blind normal saline placebo IV up to 6 cycles (at 4 week intervals) with continued randomized open-label enzalutamide. Receives: Drug: Lead-in Enzalutamide followed by Placebo/Enzalutamide |
| Darolutamide during Lead-in Period | Other | Randomized, open-label lead-in ARB (darolutamide tablets, 300 mg PO BID) for 12 weeks. Receives: Drug: Darolutamide during Lead-in Period |
| Lead-in Darolutamide followed by Radium-223/Darolutamide | Active comparator | Randomized, open-label lead-in ARB (darolutamide) for 12 weeks followed by randomized, double-blind Radium-223 IV at 55 kBq/kg IV up to 6 cycles (at 4 week intervals) with continued randomized open-label darolutamide. Receives: Drug: Lead-in Darolutamide followed by Radium-223/Darolutamide |
| Lead-in Darolutamide followed by Placebo/Darolutamide | Placebo comparator | Randomized, open-label lead-in ARB (darolutamide) for 12 weeks followed by randomized, double-blind normal saline placebo IV up to 6 cycles (at 4 week intervals) with continued randomized open-label darolutamide. Receives: Drug: Lead-in Darolutamide followed by Placebo/Darolutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Skeletal Event-free Survival (SSE-FS)
SSE-FS is a composite endpoint, composed of 4 events that indicate disease progression:
- 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
Measured: approximately 1 year and 8 months
Secondary outcomes (5)
Overall Survival (OS)
Number of subjects who survived between RT2 randomization through data cut-off.
Measured: approximately 1 year and 8 months
Time to Chemotherapy Initiation
Number of subjects who began docetaxel or cabazitaxel treatment during the study.
Measured: approximately 1 year and 8 months
Radiographic Progression-free Survival (rPFS)
Number of subjects with bone scan progression per PCWG3 criteria, and/or progression by CT/MRI per RECIST 1.1 criteria, or death from any cause following RT2. Radiological progression is interpreted by local assessment only.
Measured: approximately 1 year and 8 months
Safety Profile of Androgen Receptor Blocker (ARB) Therapy With or Without Radium-223.
Safety profile of androgen receptor blockers (enzalutamide or darolutamide) with or without radium-223; number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Reported only in the AE reporting module.
Measured: approximately 1 year and 8 months
Occurrence of AESI: Bone Fractures (Pathologic and Non-pathologic)
Assess occurrence of AESI: fractures (pathologic and non-pathologic).
Measured: approximately 1 year and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start30 Jun 2020
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Why it stopped: The study was stopped due to insurmountable enrollment challenges affecting trial accrual, resulting from the rapidly evolving treatment options for advanced prostate cancer.
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 Metastatic Castration-resistant 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
- Sequential
- Model description
- 12 week lead-in open-label androgen-receptor blocker (ARB) followed by up to 6 cycles of double-blind Radium-223 or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- MANA RBM
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Carolina Urologic Research Center, Tulane University, Barbara Ann Karmanos Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Neal Shore, MD, Study chair, Carolina Urologic Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237584
- Sponsor's protocol ID
- PC18-1005
- Acronym
- ESCALATE
- Status last verified
- Sep 2022
- First submitted
- 15 Jan 2020
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide With Radium-223 vs Enzalutamide or Darolutamide With Placebo and the Effect Upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients
- ClinicalTrials.gov ID
- NCT04237584
- Acronym / sponsor ID
- ESCALATE / PC18-1005
- Keywords
- mCRPC, ARB, Radiopharmaceutical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to insurmountable enrollment challenges affecting trial accrual, resulting from the rapidly evolving treatment options for advanced prostate cancer.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- MANA RBMUniversity, hospital or other
- Collaborators
- Bayer, Carolina Urologic Research Center, Tulane University, Barbara Ann Karmanos Cancer Institute
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Posted 7 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multi-center, double-blind, Phase III study of radium-223 plus enzalutamide or darolutamide compared to enzalutamide or darolutamide treatment plus placebo.
Detailed description
The hypothesis investigators will test in this study is whether layering radium-223 following 16 weeks of enzalutamide or darolutamide exposure in patients demonstrating a biochemical response improves disease outcomes. By adding radium-223 following a potential bone flare phenomenon [after first 12-14 weeks of therapy with an androgen receptor blocker (ARB)], including patients expected to have durable response to systemic therapy, and mandating the use of bone protective agents during treatment, the investigators aim to demonstrate an optimal time to add radium-223 in the mCRPC landscape.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- 12 week lead-in open-label androgen-receptor blocker (ARB) followed by up to 6 cycles of double-blind Radium-223 or placebo.
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide during Lead-in Period | Other | Drug: Enzalutamide during Lead-in PeriodRandomized, open-label lead-in ARB (enzalutamide tablets, 160 mg PO QD) for 12 weeks. |
| Lead-in Enzalutamide followed by Radium-223/Enzalutamide | Active comparator | Drug: Lead-in Enzalutamide followed by Radium-223/EnzalutamideRandomized, open-label lead-in ARB (enzalutamide) for 12 weeks followed by randomized, double-blind Radium-223 IV at 55 kBq/kg IV up to 6 cycles (at 4 week intervals) with continued randomized open-label enzalutamide. |
| Lead-in Enzalutamide followed by Placebo/Enzalutamide | Placebo comparator | Drug: Lead-in Enzalutamide followed by Placebo/EnzalutamideRandomized, open-label lead-in ARB (enzalutamide) for 12 weeks followed by randomized, double-blind normal saline placebo IV up to 6 cycles (at 4 week intervals) with continued randomized open-label enzalutamide. |
| Darolutamide during Lead-in Period | Other | Drug: Darolutamide during Lead-in PeriodRandomized, open-label lead-in ARB (darolutamide tablets, 300 mg PO BID) for 12 weeks. |
| Lead-in Darolutamide followed by Radium-223/Darolutamide | Active comparator | Drug: Lead-in Darolutamide followed by Radium-223/DarolutamideRandomized, open-label lead-in ARB (darolutamide) for 12 weeks followed by randomized, double-blind Radium-223 IV at 55 kBq/kg IV up to 6 cycles (at 4 week intervals) with continued randomized open-label darolutamide. |
| Lead-in Darolutamide followed by Placebo/Darolutamide | Placebo comparator | Drug: Lead-in Darolutamide followed by Placebo/DarolutamideRandomized, open-label lead-in ARB (darolutamide) for 12 weeks followed by randomized, double-blind normal saline placebo IV up to 6 cycles (at 4 week intervals) with continued randomized open-label darolutamide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Able and willing to provide informed consent.
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- Men ≥ 18 years.
- ECOG performance status of 0 or 1 at screening.
- Metastatic to bone with ≥ 2 bone metastases (area of increased uptake on 99mTc bone scan); equivocal lesions on the bone scan must be confirmed by standard X-ray, CT, or MRI.
Key exclusion criteria (16 listed)
- Pathological finding consistent with small cell carcinoma of the prostate.
- Prior chemotherapy for CRPC. Prior docetaxel for hormone-sensitive disease is permitted under the following conditions: started within 3 months of ADT initiation, given for a maximum of 6 cycles and progression occurred > 6 months after the last dose of docetaxel.
- Prior treatment for mCRPC or CRPC. However, the following therapies are permitted and not exclusionary: Sipuleucel-T, 5-alpha-reductase inhibitors, estrogens, or older antiandrogens (such as flutamide, bicalutamide, or nilutamide).
- Prior treatment for more than 2 months with CYP17 inhibitors (e.g. abiraterone or orteronel).
- Prior treatment for more than 2 months with agents inhibiting androgen receptor signaling (e.g. enzalutamide, apalutamide, or darolutamide).
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 |
|---|---|---|
| Enzalutamide during Lead-in PeriodAlso: XtandiParticipants will receive 12 weeks open-label lead-in ARB (enzalutamide) that will continue after double-blind randomization to radium-223 or placebo. | Drug | Enzalutamide during Lead-in Period |
| Lead-in Enzalutamide followed by Radium-223/EnzalutamideAlso: Xofigo, XtandiAfter a 12-week lead-in period of open-label enzalutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label enzalutamide. | Drug | Lead-in Enzalutamide followed by Radium-223/Enzalutamide |
| Lead-in Enzalutamide followed by Placebo/EnzalutamideAlso: Placebo, XtandiAfter a 12-week lead-in period of open-label enzalutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label enzalutamide. | Drug | Lead-in Enzalutamide followed by Placebo/Enzalutamide |
| Darolutamide during Lead-in PeriodAlso: NubeqaParticipants will receive 12 weeks open-label lead-in darolutamide that will continue after double-blind randomization to radium-223 or placebo. | Drug | Darolutamide during Lead-in Period |
| Lead-in Darolutamide followed by Radium-223/DarolutamideAlso: Xofigo, NubeqaAfter a 12-week lead-in period of open-label darolutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label darolutamide. | Drug | Lead-in Darolutamide followed by Radium-223/Darolutamide |
| Lead-in Darolutamide followed by Placebo/DarolutamideAlso: Placebo, NubeqaAfter a 12-week lead-in period of open-label darolutamide, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label darolutamide. | Drug | Lead-in Darolutamide followed by Placebo/Darolutamide |
Primary outcome
Symptomatic Skeletal Event-free Survival (SSE-FS)
Time frame: approximately 1 year and 8 months
SSE-FS is a composite endpoint, composed of 4 events that indicate disease progression: * 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
5 secondary outcomes
Overall Survival (OS)
Time frame: approximately 1 year and 8 months
Time to Chemotherapy Initiation
Time frame: approximately 1 year and 8 months
Radiographic Progression-free Survival (rPFS)
Time frame: approximately 1 year and 8 months
Safety Profile of Androgen Receptor Blocker (ARB) Therapy With or Without Radium-223.
Time frame: approximately 1 year and 8 months
Occurrence of AESI: Bone Fractures (Pathologic and Non-pathologic)
Time frame: approximately 1 year and 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Neal Shore, MD study chair
Carolina Urologic Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enzalutamide during Lead-in Period, Lead-in Enzalutamide followed by Radium-223/Enzalutamide and Darolutamide during Lead-in Period in people with Metastatic Castration-resistant Prostate Cancer, run by MANA RBM at 1 site 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 29 inclusion and 16 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 7 Oct 2022). 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?
Symptomatic Skeletal Event-free Survival (SSE-FS) (time frame: approximately 1 year and 8 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 7 Oct 2022.