No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Observational
Participants needed
48 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for
This trial is looking for men with advanced prostate cancer that has spread to the bones. Participants will receive radium-223 treatment and help researchers understand its effects on their cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have been diagnosed with prostate cancer
I have castration-resistant prostate cancer
I have proof of cancer spread to my bones
I have symptoms from my prostate cancer
I plan to receive radium-223 treatment
My PSA level is at least 10 ng/mL
I have low testosterone levels
You may not be able to join if
I do not have cancer that has spread to other organs
I have previously received radium-223 treatment
I have previously received platinum chemotherapy
My absolute neutrophil count is below 1.5 x 10^9/L
My hemoglobin is below 9 g/dL
My platelet count is below 100 x 10^9/L
I have a health condition that makes me unsuitable for the trial
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to stud…
This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to study the role of a DNA repair pathway in prostate cancer, specifically in response to administration of radium-223, an FDA-approved drug known to cause DNA damage to cancerous cells. Understanding how defects in the DNA repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient must be \>= 18 years of age
* Patient must have histopathologic diagnosis of prostate cancer
* Patient must have castration-resistant prostate cancer
* Patient must have radiographic evidence of bone metastasis
* Patients must be symptomatic from prostate cancer
* Pati…
Inclusion Criteria:
* Patient must be \>= 18 years of age
* Patient must have histopathologic diagnosis of prostate cancer
* Patient must have castration-resistant prostate cancer
* Patient must have radiographic evidence of bone metastasis
* Patients must be symptomatic from prostate cancer
* Patient must have plans to undergo treatment with radium-223
* Patient must have a PSA level \>= 10 ng/mL
* Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening
* Patient must have anticipated survival \> 3 months
* Patient must be willing and able to authorize consent
* Patient must be willing and able to comply with the protocol, including follow-up visits
Exclusion Criteria:
* Patient must not have visceral metastasis
* Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded
\* Bone-targeted only therapy (e.g. denosumab or zoledronic acid) will be allowed
* Patients who have received prior radium-223
* Patients who have received prior platinum containing chemotherapy
* Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L
* Hemoglobin (HB) \< 9 g/dL
* Platelets (PLT) \< 100 x 10\^9/L
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
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