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Prostate CancerPhase 2NCT00337155

BAY88-8223, Dose Finding Study in Patients With HRPC

A Phase 2 study testing Radium-223 dichloride (BAY88-8223) in people with Prostate Cancer and Neoplasm Metastasis, 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

The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Neoplasm Metastasis
What is being tested?
Radium-223 dichloride (BAY88-8223)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteUnited Kingdom
Study dates
May 2006to Dec 2009
Phase
Phase 2
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 PSA:
  • Patient must be maintained on androgen ablation therapy with LHRH agonist (stable dose for at least 8 weeks prior to study entry), or have undergone orchiectomy
  • Serum testosterone level is required to be ≤ 50 ng/dl
  • Patients who have received prior hormonal drug therapy:
  • Flutamide, nilutamide or cyproterone acetate must have stopped at least four weeks prior to study drug administration and progression must have been demonstrated since cessation;
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  • Bicalutamide must have stopped at least six weeks prior to study drug administration and progression must have been demonstrated since cessation
  • Elevated and rising PSA:
  • Baseline PSA level ≥ 10 ng/ml
  • 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 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 patient will still be eligible provided the next PSA measure (measure 4)is found to be greater than the second PSA value(measure 2).3. Multifocal skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
  • Performance status: ECOG 0-2
  • Life expectancy: At least 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
  • ASAT and ALAT ≤ 2,5 times upper institutional limit of the normal range
  • The patient is willing and able to comply with the protocol (including maintenance of patient diary), and agrees to return to the hospital for follow-up visits and examination
  • The patient has been fully informed about the study and has signed the informed consent form

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 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
  • Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
  • Visceral metastases from prostate cancer as assessed by abdominal/pelvic CT or MRI within six weeks before administration of study drug; Lung lesions from prostate cancer as assessed by chest X-ray within 6 weeks. This requirement does not include abdominal or pelvic lymph node involvement (individual lymph node size must not exceed 1 cm in short diameter) which is acceptable
  • 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 5RT

Other trials in United Kingdom

About this study

Official title: A Double Blind, Randomised, Dose Finding, Repeat Dose, Phase II, Multicentre Study of Alpharadin® for the Treatment of Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases

The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.

Being tested
Radium-223 dichloride (BAY88-8223)
Keywords
Recurrent Prostate Cancer, metastatic Cancer
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

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

    3 doses of radium-223 at different dose levels, 25, 50 or 80 kBq/kg b.w.given as injection.

Study groups in NCT00337155
Study groupRoleWhat they receive
Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 1Experimental25 kBq/kg b.w., 3 times at 6 week intervals
Receives: Drug: Radium-223 dichloride (BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 2Experimental50 kBq/kg b.w., 3 times at 6 week intervals
Receives: Drug: Radium-223 dichloride (BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 3Experimental80 kBq/kg b.w., 3 times at 6 week intervals
Receives: Drug: Radium-223 dichloride (BAY88-8223)

What is being measured

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

  1. Proportion of participants in each dose group with a confirmed PSA response

    PSA response; each patient will be classified as PSA responder/non-responder according to the definition of PSA response:a decrease from baseline of at least 50% maintained for at least three weeks.

    Measured: 24 weeks, 12 months, 24 months

Secondary outcomes (8)

  1. The maximum percent decrease in PSA level compared to baseline

    Measured: 24 weeks, 12 months, 24 months

  2. Time to PSA Progression

    Measured: 24 weeks, 12 months, 24 months

  3. Bone-ALP response (classified as for PSA response) and decrease in bone-ALP level compared to baseline

    Measured: 24 weeks, 12 months, 24 months

  4. Total number of SRE per patient

    Measured: 24 weeks, 12 months, 24months

  5. Pain Assessment and analgesic consumption

    Measured: 24 weeks, 12 months, 24months

  6. Time to death from first treatment

    Measured: 24 weeks, 12 months, 24months

  7. Time to Skeletal Related Events (SRE)

    Measured: 24 weeks, 12 months, 24 months

  8. Adverse events, blood chemistry and haematological toxicity

    Measured: 24 weeks, 12 months, 24 months

Timeline

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

  1. First posted15 Jun 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionDec 2008
  4. Study completionDec 2009

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
Double blind
Who is masked
Participant, Investigator
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00337155
Sponsor's protocol ID
15304
Other IDs
2005-003680-22, BC1-04, 2005
Status last verified
Dec 2014
First submitted
13 Jun 2006
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
No

Publications

  • Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germa JR, O'Bryan-Tear CG, Haider T, Hoskin P. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013 Feb;63(2):189-97. doi: 10.1016/j.eururo.2012.09.008. Epub 2012 Sep 13.

    PubMed 23000088

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radium-223 dichloride (BAY88-8223) in people with Prostate Cancer and Neoplasm Metastasis, 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 20 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: finished, as of the sponsor's last update on 2 Nov 2023. 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 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?

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?

Proportion of participants in each dose group with a confirmed PSA response (time frame: 24 weeks, 12 months, 24 months). 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 NCT00337155, 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 2 Nov 2023.

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BAY88-8223, Dose Finding Study in Patients With HRPC | AzTrials