BAY88-8223, Does Response Study in HRPC Patients (NCT00667199) | Clinical Trial Compass
CompletedPhase 2
BAY88-8223, Does Response Study in HRPC Patients
100 participantsStarted 2005-05-30
Plain-language 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.
Who can participate
Age range40 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, has been recently withdrawn must demonstrate progression of disease and be at last 4 weeks beyond the discontinuation of such agents; for bicalutamide 6 weeks is required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 ana…
What they're measuring
1
Pain Assessment (using a 100mm Visual Analogue Scale)