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Prostatic NeoplasmsPhase 3NCT01810770

Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis

A Phase 3 study testing Radium-223 dichloride (Xofigo, BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 27 sites in 4 countries.

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

To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone. 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)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
243 participants
Where
27 sitesin 4 countries
Study dates
26 Mar 2013to 25 Sep 2017
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

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Patients diagnosed with progressive bone predominant metastatic Castration-Resistant Prostate Cancer (CRPC) /Hormone Refractory Prostate Cancer (HRPC) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
  • Known hormone refractory disease
  • No intention to use cytotoxic chemotherapy within the next 6 months
  • Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with external bean radiation therapy (EBRT) for bone pain within previous 12 weeks
  • Age >/= 18 years
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  • Race is Asian
  • Eastern Co-operative Oncology Group (ECOG) Performance Status (PS): 0-2
  • Life expectancy >/= 6 months
  • Adequate bone marrow, liver and renal function as assessed by the Laboratory required by protocol

Who cannot join

  • Treatment with an investigational drug within previous 4 weeks prior to screening, or planned during the treatment or follow-up periods
  • Eligible for docetaxel treatment, i.e. subjects who are fit enough, willing and who are located where treatment with docetaxel is available
  • Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks prior to screening (however ongoing neuropathy is permitted)
  • Prior hemibody external radiotherapy is excluded. Subjects who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets.
  • Received systemic therapy radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
  • Blood transfusion or erythropoetin stimulating agents within the previous 4 weeks prior to screening
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  • Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
  • Visceral metastases as assessed by abdominal/pelvic computed tomography (CT) or other imaging modality
  • Presence of brain metastases
  • Lymphadenopathy exceeding 3 cm in short-axis diameter
  • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
  • Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered.
  • Received local practice implant therapy containing lodine-125 or Palladium-103 for the primary lesion of prostate cancer within the 6 months prior to screening.
  • Any other serious illness or medical condition

Trial locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

China15 sites

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100029

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100730

  • Study site

    Guangzhou, Guangdong, 510060

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Guangzhou

  • Study site

    Nanjing, Jiangsu, 210008

  • Study site

    Nanjing, Jiangsu, 210009

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200040

  • Study site

    Shanghai, 200072

  • Study site

    Shanghai, 200127

  • Study site

    Shanghai, 200433

Other trials in China

Singapore4 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 169610

  • Study site

    Singapore, 258499

  • Study site

    Singapore

Other trials in Singapore

South Korea4 sites

  • Study site

    Donggu, Gwangju Gwang''yeogsi, 61469

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 06351

Other trials in South Korea

Taiwan4 sites

  • Study site

    Kaohsiung City, 81362

  • Study site

    Taipei, 10002

  • Study site

    Taipei City, Taipei, 112

  • Study site

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: A Single-arm, International, Prospective, Interventional, Open-label, Multicenter Study of Radium-223 Dichloride in the Treatment of Patients With Castration-Resistant Prostate Cancer (CRPC) With Bone Metastasis.

To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.

Being tested
Radium-223 dichloride (Xofigo, BAY88-8223)
Keywords
Radium-223 Dichloride, Prostatic Neoplasms, Bone Metastasis
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, 55 kBq/kg body weight, will be administered as a slow bolus IV injection at 4 week intervals for up to 6 doses.

Study groups in NCT01810770
Study groupRoleWhat they receive
Radium-223 dichlorideExperimentalNot described
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

What is being measured

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

  1. Number of participants with adverse events as a measure of safety and tolerability

    Measured: Up to 36 months

  2. Number of participants with laboratory changes

    Measured: Up to 36 months

  3. Number of participants with changes in vital signs

    Measured: Up to 36 months

  4. Number of participants with changes in electrocardiogram (ECG)

    Measured: Up to 36 months

  5. Overall Survival (OS)

    OS is defined as the time from date of first study drug treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

    Measured: Up to 36 months

Secondary outcomes (12)

  1. Changes in total Alkaline Phosphate (ALP) in serum

    Measured: Up to 36 months

  2. Number of participants with total-ALP normalization

    Measured: Up to 36 months

  3. Time to total ALP progression

    Measured: Up to 36 months

  4. Changes in prostate specific antigen (PSA) in serum

    Measured: Up to 36 months

  5. Time to PSA progression

    Measured: Up to 36 months

  6. Time to first skeletal related event (SRE)

    Measured: Up to 36 months

  7. SRE free survival

    Measured: Up to 36 months

  8. Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms

    Measured: Up to 36 months

  9. Time to occurrence of first start of any other anti-cancer treatment

    Measured: Up to 36 months

  10. Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

    Measured: Up to 36 months

  11. Quality of life (QoL)

    QoL is assessed by the scores got from the Functional Assessment of Cancer Therapy in subjects with prostate cancer (FACT-P) questionnaire, EuroQoL (EQ-5D) questionnaire, and the BPI-SF questionnaire.

    Measured: Up to 36 months

  12. Time to pain progression

    Measured: Up to 36 months

Timeline

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

  1. First posted14 Mar 2013 (estimated)
  2. Study start26 Mar 2013
  3. Primary completion25 Sep 2017
  4. Study completion25 Sep 2017

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01810770
Sponsor's protocol ID
15397
Status last verified
Sep 2018
First submitted
12 Mar 2013
Last updated
19 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radium-223 dichloride (Xofigo, BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 27 sites in 4 countries.

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 10 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: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China, Singapore, South Korea, Taiwan. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 adverse events as a measure of safety and tolerability (time frame: Up to 36 months). The study lists 5 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 NCT01810770.

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 19 Sep 2018.

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Clinical Trial NCT01810770 | AzTrials