BAY88-8223, Dose Finding Study in Patients With HRPC

NCT00337155 | Completed Phase 2

• 3 other identifiers: 153042005-003680-22BC1-04
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Neoplasm Metastasis

Keywords

Recurrent Prostate Cancer; metastatic Cancer

Outcome Measures

Primary Outcomes (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.

  24 weeks, 12 months, 24 months

Secondary Outcomes (8)

• The maximum percent decrease in PSA level compared to baseline

  24 weeks, 12 months, 24 months

• Time to PSA Progression

  24 weeks, 12 months, 24 months

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

  24 weeks, 12 months, 24 months

• Total number of SRE per patient

  24 weeks, 12 months, 24months

• Pain Assessment and analgesic consumption

  24 weeks, 12 months, 24months

Study Arms (3)

Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 1

EXPERIMENTAL

25 kBq/kg b.w., 3 times at 6 week intervals

Drug: Radium-223 dichloride (BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 2

EXPERIMENTAL

50 kBq/kg b.w., 3 times at 6 week intervals

Drug: Radium-223 dichloride (BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 3

EXPERIMENTAL

80 kBq/kg b.w., 3 times at 6 week intervals

Drug: Radium-223 dichloride (BAY88-8223)

Interventions

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.

Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 1; Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 2; Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Sutton, Surrey, SM2 5RT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23000088 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: November 2, 2023

Record last verified: 2014-12

Locations

GB (1)