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Prostatic NeoplasmsPhase 1NCT00667537

PK in Pts With HRPC & Skeletal Metastes

A Phase 1 study testing Radium-223 chloride (Xofigo®, BAY88-8223) injection in people with Prostatic Neoplasms, run by Bayer at 1 site in United Kingdom.

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

Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart). 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 chloride (Xofigo®, BAY88-8223) injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2007to Dec 2008
Phase
Phase 1
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
  • Hormone refractory with evidence of rising prostate-specific antigen (PSA): Subject must be maintained on androgen ablation therapy with luteinizing hormone-releasing hormone agonist or have undergone bilateral orchiectomy
  • Serum testosterone level required to be ≤50 ng/dL
  • Subjects who have received prior antiandrogen drug therapy: Flutamide, nilutamide, or cyproterone acetate must have stopped at least 4 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation; bicalutamide must have stopped at least 6 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation
  • PSA progression: Progressive rise in PSA, defined as two consecutive increases in PSA documented over a previous reference value (measure 1). The first increase in PSA (measure 2) should occur at a minimum of 1 week from the reference value (measure 1). This increase in PSA should be confirmed (measure 3) after a minimum of 1 week. If the confirmatory PSA value (measure 3) is less than the previous value, the subject will still be eligible provided the next PSA measure (measure 4) is found to be greater than the second PSA value (measure 2)
  • Skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
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  • Performance status: Eastern Co-operative Oncology Group (ECOG) 0-2
  • Life expectancy: ≥6 months
  • Laboratory requirements: Neutrophil count ≥1.5 x 109/L, platelet count ≥100 x109/L, haemoglobin ≥95 g/L, total bilirubin level within normal institutional limits, aspartate aminotransferase and alanine aminotransferase ≤2.5 times upper institutional limit of the normal range, S Creatinine ≤1.5 times upper institutional limit of the normal range

Who cannot join

  • Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
  • Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
  • More than one regimen of previous cytotoxic chemotherapy
  • Has received prior hemibody external radiotherapy
  • Has a need for immediate external radiotherapy
  • Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
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  • Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for >/= 12 weeks before administration of study drug
  • Patients who are </= 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
  • Patients who have started or stopped systemic steroids, within a week prior to study drug administration, or are expected to be subject to changes in the systemic steroid medication
  • Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
  • Visceral (e.g. liver, lung) metastases from prostate cancer as assessed by abdominal/ pelvic CT or chest radiograph within six weeks before administration of study drug
  • Lymph node metastases with short-axis diameter greater than 2 cm
  • Bulky loco-regional disease
  • Any other serious illness or medical condition, for example: any uncontrolled infection, any patient who has clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or any patient who has heart failure more severe than this (NYHA Heart Failure Class III or IV), Crohns disease or ulcerative colitis

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Study site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase I, Open-label, Dosimetry, Biodistribution and Pharmacokinetic Study of Alpharadin™ in Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases

Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart).

Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection

Being tested
Radium-223 chloride (Xofigo®, BAY88-8223) injection
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 chloride (Xofigo®, BAY88-8223) injectionDrug

    Sterile, clear and colourless aqueous solution of radium-223 chloride free of endotoxins, for intravenous administration

Study groups in NCT00667537
Study groupRoleWhat they receive
Radium-223 chlorideExperimentalIV administrations of 100 kBq/kg b.w (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization). Two administrations took place with an interval of 6 weeks
Receives: Drug: Radium-223 chloride (Xofigo®, BAY88-8223) injection

What is being measured

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

  1. Estimation of whole-body retention of radioactivity at each imaging time post-injection

    Measured: 1 week

  2. Estimation of the individual organ uptake/retention of radioactivity at each time-point post injection

    Measured: 1 week

  3. Estimate retention of administered radioactivity in blood

    Measured: Up to 1 week

  4. Estimation of elimination of radioactivity in urine and faeces

    Measured: 2 days

  5. Calculation of estimated absorbed radiation dose to target organs

    Measured: 1 week

  6. Pharmacokinetics

    Measured: 1 week

Secondary outcomes (8)

  1. Comparison of the biodistribution and dosimetry after the first and second injection

    Measured: 7 weeks

  2. Prostate specific antigen (PSA) response

    PSA decline, defined as the number of patients with a confirmed ≥50% reduction in PSA level after treatment with respect to the pre-injection PSA level and the time to PSA progression after PSA response

    Measured: At baseline, before injections, and at 2 month intervals during the 12 month follow up period

  3. Survival

    Measured: 6 and 12 months after the first injection

  4. Adverse events

    Measured: 1 year

  5. Laboratory variables; serum biochemistry and haematology

    Measured: 1 year

  6. Vital signs

    Systolic/diastolic blood pressure, respiratory rate, heart rate and body temperature

    Measured: 12 weeks

  7. ECG (12 leads)

    Electrocardiogram (12 leads)

    Measured: 12 weeks

  8. Physical examination

    Measured: 1 year

Timeline

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

  1. First posted28 Apr 2008 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

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 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00667537
Sponsor's protocol ID
15302
Other IDs
2006-006101-88, BC1-05
Status last verified
Dec 2015
First submitted
24 Apr 2008
Last updated
14 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Cook G Jr, Parker C, Chua S, Johnson B, Aksnes AK, Lewington VJ. 18F-fluoride PET: changes in uptake as a method to assess response in bone metastases from castrate-resistant prostate cancer patients treated with 223Ra-chloride (Alpharadin). EJNMMI Res. 2011 Jun 7;1(1):4. doi: 10.1186/2191-219X-1-4.

    PubMed 22214491

  • Chittenden SJ, Hindorf C, Parker CC, Lewington VJ, Pratt BE, Johnson B, Flux GD. A Phase 1, Open-Label Study of the Biodistribution, Pharmacokinetics, and Dosimetry of 223Ra-Dichloride in Patients with Hormone-Refractory Prostate Cancer and Skeletal Metastases. J Nucl Med. 2015 Sep;56(9):1304-9. doi: 10.2967/jnumed.115.157123. Epub 2015 Jul 16.

    PubMed 26182965

  • Hindorf C, Chittenden S, Aksnes AK, Parker C, Flux GD. Quantitative imaging of 223Ra-chloride (Alpharadin) for targeted alpha-emitting radionuclide therapy of bone metastases. Nucl Med Commun. 2012 Jul;33(7):726-32. doi: 10.1097/MNM.0b013e328353bb6e.

    PubMed 22513884

  • Hobbs RF, Song H, Watchman CJ, Bolch WE, Aksnes AK, Ramdahl T, Flux GD, Sgouros G. A bone marrow toxicity model for (2)(2)(3)Ra alpha-emitter radiopharmaceutical therapy. Phys Med Biol. 2012 May 21;57(10):3207-22. doi: 10.1088/0031-9155/57/10/3207. Epub 2012 May 1.

    PubMed 22546715

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radium-223 chloride (Xofigo®, BAY88-8223) injection in people with Prostatic Neoplasms, run by Bayer at 1 site in United Kingdom.

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 9 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 14 Dec 2015. 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 Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Estimation of whole-body retention of radioactivity at each imaging time post-injection (time frame: 1 week). The study lists 6 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 NCT00667537, which also lists 4 linked publications.

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 Dec 2015.

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