AzTrials
AzTrials

Prostatic NeoplasmsNCT01516762

Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

A study testing Radium-223 dichloride (BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 60 sites in United States.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product. 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 (BAY88-8223)
Type of treatment
Injection or infusion
How many people
Not given
Where
60 sitesUnited States
Study dates
Start not givento not given
Phase
Expanded access
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
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Histologically or cytologically confirmed prostate cancer
  • Patients diagnosed with symptomatic progressive bone predominant metastatic CRPC/HRPC with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
  • Symptomatic is defined as either
  • Regular (not occasional) use of analgesic medication for cancer related bone pain (≥ level 1; World Health Organization [WHO] ladder for cancer pain), or
  • Treatment with external beam radiation therapy (EBRT) for bone pain (the EBRT should be within the last 12 weeks before treatment)
Show all 20Show fewer
  • Progressive disease is defined either by:
  • The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), then PSA values from 3 assessments within the last 6 months must be provided; OR
  • In the absence of new bone lesions, 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but, the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met).
  • No intention to use cytotoxic chemotherapy within the next 6 months
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
  • Adequate hematological, liver, and renal function
  • Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
  • Platelet count ≥ 100 x10^9/L
  • Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
  • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Creatinine ≤ 1.5 x ULN
  • Albumin > 25 g/L *Any bone imaging techniques as per institutional standard of care

Who cannot join

  • Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
  • Eligible for first course of docetaxel, i.e., patients 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 (AEs) due to cytotoxic chemotherapy administered more than 4 weeks previous prior to screening (however, ongoing neuropathy is permitted)
  • Prior hemibody external radiotherapy is excluded. Patients 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 with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
  • Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
Show all 17Show fewer
  • Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
  • Presence of brain metastases
  • Lymphadenopathy exceeding 6 cm in short-axis diameter
  • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
  • Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
  • Any other serious illness or medical condition, such as but not limited to:
  • Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
  • Cardiac Failure New York Heart Association (NYHA) Class III or IV
  • Crohn's disease or ulcerative colitis
  • Bone marrow dysplasia
  • Fecal incontinence

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Study site

    Ann Arbor, Michigan, 48109-0028

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21201-1595

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bethesda, Maryland, 20889

  • Study site

    Birmingham, Alabama, 35233

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Fort Myers, Florida, 33901

  • Study site

    Goshen, Indiana, 46526

  • Study site

    Greenbrae, California, 94904

  • Study site

    Hampton, Virginia, 23666

  • Study site

    Honolulu, Hawaii, 96813-2413

  • Study site

    Houston, Texas, 77030

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    La Jolla, California, 92093

  • Study site

    Las Vegas, Nevada, 89169

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Milwaukee, Wisconsin, 53226-3596

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    Myrtle Beach, South Carolina, 29577

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Brunswick, New Jersey, 08903-2681

  • Study site

    New Hyde Park, New York, 11040-1496

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10065

  • Study site

    Newark, Delaware, 19718

  • Study site

    Newark, New Jersey, 07103

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Philadelphia, Pennsylvania, 19111-2497

  • Study site

    Philadelphia, Pennsylvania, 19401

  • Study site

    Phoenix, Arizona, 85040

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Plano, Texas, 75093

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Rockville, Maryland, 20850

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Francisco, California, 94143

  • Study site

    Scottsdale, Arizona, 85260

  • Study site

    Seattle, Washington, 98122

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    Springfield, Oregon, 97477

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stanford, California, 94305

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tampa, Florida, 33612

  • Study site

    Temple, Texas, 76508

  • Study site

    Washington D.C., District of Columbia, 20007

  • Study site

    Washington D.C., District of Columbia, 20060

  • Study site

    Wheeling, West Virginia, 26003

Other trials in United States

About this study

Official title: Radium-223 Chloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product.

Being tested
Radium-223 dichloride (BAY88-8223)
Keywords
Radium 223, Alpharadin, Prostate Cancer, Bone metastases, Castrate resistant prostate cancer, Hormone refractory prostate cancer
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 (BAY88-8223)Drug

    One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.

Timeline

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

  1. First posted25 Jan 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516762
Sponsor's protocol ID
15995
Other IDs
2011-004469-33
Status last verified
Jul 2014
First submitted
20 Jan 2012
Last updated
14 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Radium-223 dichloride (BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 60 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 20 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 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.

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516762.

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 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in