Prostatic Neoplasms Clinical Trial
Official title:
A Re-treatment Safety Study of Radium-223 Dichloride in Subjects With Castration-resistant Prostate Cancer With Bone Metastases Who Received an Initial Course of Six Doses of Radium-223 Dichloride 50 kBq/kg Every Four Weeks
Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and
experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common
Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the
initial course of radium-223 dichloride that led to the discontinuation of treatment. 40
Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg
IV every 4 weeks.
The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit
every 4 weeks, prior to receiving radium-223 dichloride.
After the end of treatment visit the subjects will enter the active follow up period. Related
AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12
weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride.
After the 2 years of active follow-up, subjects will enter the long-term follow-up period and
will be followed via telephone follow-up at 6-month intervals for late toxicities and
survival up to 7 years after the last dose of radium-223 dichloride or until death.
Joint safety reviews will regularly take place to oversee safety of the subjects conducted at
regular intervals.
An interim analysis of the safety data will be conducted during the study.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04964271 -
Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants
|
||
Completed |
NCT02546908 -
A Registry of Participants With Prostate Cancer in Asia
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT01683994 -
Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04838613 -
Study of Diagnostic Performance of [18F]CTT1057 in BCR
|
Phase 3 | |
Completed |
NCT02364531 -
A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
|
||
Completed |
NCT01929655 -
Japanese BAY88-8223 Monotherapy Phase II Study
|
Phase 2 | |
Active, not recruiting |
NCT05022849 -
A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants
|
Phase 1 | |
Completed |
NCT03261999 -
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
|
Phase 3 | |
Terminated |
NCT04907227 -
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension
|
Phase 3 | |
Active, not recruiting |
NCT03587285 -
A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT02217566 -
Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
|
Phase 2 | |
Not yet recruiting |
NCT04101305 -
Measurement of Circulating Tumor Cells in Prostate Cancer
|
||
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Withdrawn |
NCT02905201 -
A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
N/A | |
Terminated |
NCT03066154 -
Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer
|
Phase 1 | |
Completed |
NCT02692976 -
Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients
|
Phase 2 | |
Terminated |
NCT01420965 -
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
|
Phase 2 | |
Completed |
NCT01441713 -
Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer
|
N/A |