Loading clinical trials...

BAY88-8223, Does Response Study in HRPC Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

BAY88-8223, Does Response Study in HRPC Patients

A Double Blind, Dose Response Phase II, Multicentre Study of Radium 223 (Alpharadin®) for the Palliation of Painful Bone Metastases in Hormone Refractory Prostate Cancer Patients

NCT00667199•Bayer

View on ClinicalTrials.gov

Summary

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

Detailed Description

The study is designed to investigate whether there is a dose-response relationship for radium-223 in patients with painful bone metastases secondary to prostate carcinoma regarding palliation of bone pain. The palliative efficacy will be established through assessments of bone pain and consumption of analgesia. Furthermore, the aim is to find the most efficient dose with an acceptable safety profile. The safety will be assessed through measurements of adverse events, and acute haematological toxicity during the study period. Long-term chronic toxicity, and the overall survival at one and two years post treatment will also be assessed. This is a double-blind, dose-response, randomized, multi-centre phase II efficacy and safety study of radium- 223. The clinical sites will enroll a total of 100 eligible patients. The treatment is a single intravenous administration of radium-223. The target population is patients suffering from bone pain due to skeletal metastasis secondary to hormone refractory prostate cancer.

Eligibility

Age

40 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically/cytologically confirmed adenocarcinoma of the prostate
•Patient is hormone refractory with evidence of progressive disease:
•* Patient must be maintained on androgen ablation therapy with LHRH agonist or have undergone orchiectomy
•* Patient's testosterone level is required to be equal to or below 50 ng/dl
•* Patients in which flutamide, nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, has been recently withdrawn must demonstrate progression of disease and be at last 4 weeks beyond the discontinuation of such agents; for bicalutamide 6 weeks is required
•* Increase in PSA levels in two consecutive measurements with at least one week apart, demonstrating an increase over the reference (nadir) value, and with the final PSA \>/= 5 ng/ml
•* A reference PSA (nadir) value must be measured at least 4 weeks after the discontinuation of flutamide, nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, and at least 6 weeks after discontinuation of bicalutamide
•* If the third PSA value is lower than the second value, the patient could still be eligible, provided a fourth measurement obtained at least 1 week after the third PSA value, is grater than the second PSA value and \>/= 5 ng/ml
•Multifocal (\>1) skeletal metastases confirmed by bone scintigraphy within 6 weeks
•Bone pain with a score of at least 2 on BPI average pain, despite adequate use of analgesics, that correlates with areas of increased uptake (osteoblastic activity) on bone scintigraphy
+11 more criteria

Exclusion Criteria

•Has received an investigational drug within 4 weeks before the administration of radium-223, or is scheduled to receiving one during the study period
•Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
•Has received prior hemibody 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 inclusion
•Has started treatment with bisphosphonates less than 3 months prior to administration of study drug
•Patients experiencing hormone withdrawal syndrome, or are \</= 4 weeks post withdrawal of antiandrogen therapy (6 weeks for bicalutamide)
•Patients who have started steroids or changed to treatment with steroids within the last 4 weeks prior to administration of radium-223
•Has other clinically significant or symptomatic disease, which might interfere with the assessment of bone pain, e.g. spinal cord compression, compression or infiltration of a neural plexus, nerve root or peripheral nerves
•Other currently active (relapse within the last 3 year) malignancy (except non-melanoma skin cancer), or known brain or visceral metastases dominating the clinical picture of the patient
•Other serious illness or medical condition:
+4 more criteria

Key Dates

Start Date

May 30, 2005

Primary Completion Date

April 1, 2008

Completion Date

October 6, 2009

Last Updated

April 19, 2023

Enrollment

100

ACTUAL participants

Conditions

Hormone Refractory Prostate CancerBone Metastases

Interventions

Radium-223 dichloride (BAY88-8223)

DRUG

Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases

NCT07202273

Bone Metastases

View study

RECRUITINGNA

SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

NCT06987370

Bone Metastases in Subjects With Advanced Cancer

View study

ENROLLING_BY_INVITATIONNA

EXercise Enhancement After RadioTherapy for Bone Metastases

NCT06470503

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

BAY88-8223, Does Response Study in HRPC Patients

Inclusion Criteria

Exclusion Criteria

Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases

SFRT and SCART in Radiotherapy for Bone Metastases With Soft Tissue

EXercise Enhancement After RadioTherapy for Bone Metastases

Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases

The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment

FDG PET/CT in Breast Cancer Bone Mets