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Prostatic NeoplasmsPhase 2NCT02034552

A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)

A Phase 2 study testing Radium-223 dichloride (Xofigo, BAY88-8223), Abiraterone acetate and Prednisone in people with Prostatic Neoplasms, run by Bayer at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective in this study is to evaluate bone scan response at Week 24 based on the quantified technetium-99 bone scan lesion area (BSLA). The safety of radium-223 dichloride in combination with abiraterone acetate or enzalutamide will be investigated. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Radium-223 dichloride (Xofigo, BAY88-8223), Abiraterone acetate and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
19 sitesUnited States
Study dates
7 Mar 2014to 26 Jun 2018
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

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Known castration-resistant disease
  • Serum PSA ≥2 ng/mL (μg/L)
  • Multiple skeletal metastases (≥2 hot spots) on bone scan
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
  • Life expectancy ≥6 months
  • Adequate hematologic, hepatic, and renal function

Who cannot join

  • History of visceral metastasis, or visceral metastases
  • Malignant lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
  • Medical condition that would make prednisone (corticosteroid) use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone bid
  • Treatment with more than one chemotherapy agent for prostate cancer
  • Prior systemic radiotherapy and hemibody external radiotherapy
Show all 11Show fewer
  • History of pituitary or adrenal dysfunction
  • Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
  • Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
  • History of seizures (taking/not taking anticonvulsants), arteriovenous malformation in the brain, head trauma with loss of consciousness
  • Central nervous system (CNS) metastases

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Houston, Texas, 77027

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Los Angeles, California, 90033

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    Newark, Delaware, 19713

  • Study site

    Omaha, Nebraska, 68130

  • Study site

    Plantation, Florida, 33324

  • Study site

    Rockville, Maryland, 20850

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Seattle, Washington, 98109

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Springfield, Oregon, 97477

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Syracuse, New York, 13210

  • Study site

    The Bronx, New York, 10467-2490

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Randomized Open-label Phase IIa Study Evaluating Quantified Bone Scan Response Following Treatment With Radium-223 Dichloride Alone or in Combination With Abiraterone Acetate or Enzalutamide in Subjects With Castration-resistant Prostate Cancer Who Have Bone Metastases

The primary objective in this study is to evaluate bone scan response at Week 24 based on the quantified technetium-99 bone scan lesion area (BSLA). The safety of radium-223 dichloride in combination with abiraterone acetate or enzalutamide will be investigated. The study will evaluate radiological progression free survival, overall survival, and skeletal events. This study will also explore the clinical utility of different imaging modalities (whole body quantified technetium-99 bone scan, DW-MRI [diffusion-weighted magnetic resonance imaging] and NaF [sodium fluoride] PET-CT [positron emission tomography-computed tomography] scan) and will have a separate central radiological review for applicable secondary and exploratory imaging endpoints. All subjects will be randomized as assigned randomly by the IXRS (interactive voice / web response system) system in a 1:1:1 ratio into one of the treatment arms: radium-223 dichloride alone, 50 kBq/kg (55 kBq/kg after implementation of NIST [National Institute of Standards and Technology] update) every 4 weeks for up to 6 doses; radium-223 dichloride, 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks up to 6 doses together with abiraterone acetate 1,000 mg daily and prednisone 5 mg bid (twice daily); radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks up to 6 doses together with enzalutamide 160 mg daily. The study will consist of screening, treatment and follow-up periods. Study will continue until disease progression as determined by investigator, or when patient meets criteria for withdrawal from study. Subjects in treatment arms with abiraterone/prednisone or enzalutamide will have the option to continue taking oral study therapy until the end of the study (2 years from the last dose of radium-223 dichloride) if the investigator deems the subject may benefit and there is no clinical or radiological progression. Subjects who discontinue all study treatment prior to 2 years from last radium-223 dichloride treatment will enter active follow-up. During the active follow-up period, the subject will have a safety visit at the clinic every 12 weeks from the EOT (end of treatment) for up to 2 years from the last dose of radium-223 dichloride. Beyond 2 years from last radium-223 dichloride treatment,subjects will enter long-term follow-up and will be followed via phone contact at intervals to assess for safety (hematological toxicity and new primary malignancies) and overall survival. A separate long-term safety follow-up study protocol is planned. Once implemented, the study subjects surviving after the end of the active follow-up will be transitioned to this separate long-term safety follow-up protocol.

Being tested
Radium-223 dichloride (Xofigo, BAY88-8223), Abiraterone acetate, Prednisone, Enzalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radium-223 dichloride (Xofigo, BAY88-8223)Drug

    Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg (55 kBq/kg after implementation of NIST [National Institute of Standards and Technology] update) every 4 weeks x 6 doses intravenous slow bolus

  • Abiraterone acetateDrug

    Abiraterone acetate 1000 mg (4 x 250 mg tablets) taken orally once daily for up to two years following last dose of radium-223 dichloride

  • PrednisoneDrug

    Prednisone 5 mg capsule taken orally twice daily for up to two years following last dose of radium-223 dichloride

  • EnzalutamideDrug

    Enzalutamide 160 mg (four 40 mg capsules) taken orally once daily for up to two years following last dose of radium-223 dichloride

Study groups in NCT02034552
Study groupRoleWhat they receive
Radium-223 dichloride (Xofigo, BAY88-8223)ExperimentalNot described
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 with abiraterone&prednisoneExperimentalNot described
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Abiraterone acetate; Drug: Prednisone
Radium-223 with enzalutamideExperimentalNot described
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Bone Scan Response Rate

    Radiological bone scan response based on change from baseline of digitized technetium-99 bone scans using computer-aided detection software. Responder (R): 30% or greater resolution of the BSLA compared to baseline. Stable Disease (SD): Not meeting the criteria for R, PD, or UE. Progressive Disease (PD): Two or more new areas of radiotracer uptake attributable to metastatic disease in regions of bone that had not previously shown radiotracer uptake or greater than 30% increase from baseline in BSLA attributable to metastatic disease. Unable to Evaluate (UE): Assigned if bone scan results cannot be interpreted due to inconsistent image acquisition parameters compared to the reference scan, incomplete imaging, or other similar technical deficiencies.

    Measured: At 24 weeks

  2. Bone Scan Lesion Area

    Bone scan lesion area was defined as the sum of the pixel areas (cm2) of the set of the whole body technetium-99 bone scan imaging pixels identified as bone lesion.

    Measured: At 24 weeks

Secondary outcomes (6)

  1. Radiological Progression Free Survival

    Measured: From randomization to radiological disease progression or death from any cause (about 30.82 months )

  2. Time to Radiological Progression

    Measured: From the randomization date to the date of radiological disease progression (about 30.82months)

  3. Time to Radiological Bone Progression

    Measured: From the randomization date to the date of radiological bone progression (about 30.82 months)

  4. Time to First Symptomatic Skeletal Event

    Measured: From the randomization date to the first SSE on or following the randomization date (about 30.82 months)

  5. Symptomatic Skeletal Event-free Survival

    Measured: From the randomization date to the first SSE on or following the randomization date or death, whichever occurred first (about 32.39 months)

  6. Overall Survival

    Measured: From the randomization date to the date of death due to any cause (about 42.94 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2014 (estimated)
  2. Study start7 Mar 2014
  3. Primary completion15 Jul 2016
  4. Study completion26 Jun 2018

Resources

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02034552
Sponsor's protocol ID
16544
Status last verified
Jul 2019
First submitted
16 Dec 2013
Last updated
23 Jul 2019
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Petrylak DP, Vaishampayan UN, Patel KR, Higano CS, Albany C, Dawson NA, Mehlhaff BA, Quinn DI, Nordquist LT, Wagner VJ, Siegel J, Trandafir L, Sartor O. A randomized phase IIa study of quantified bone scan response in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 dichloride alone or in combination with abiraterone acetate/prednisone or enzalutamide. ESMO Open. 2021 Apr;6(2):100082. doi: 10.1016/j.esmoop.2021.100082. Epub 2021 Mar 19.

    PubMed 33744812

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radium-223 dichloride (Xofigo, BAY88-8223), Abiraterone acetate and Prednisone in people with Prostatic Neoplasms, run by Bayer at 19 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 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in 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 2 Jul 2017). 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?

Patient Bone Scan Response Rate (time frame: At 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02034552, which also lists 1 linked publication.

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 23 Jul 2019.

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