Advanced Prostate Cancer Clinical Trial
Official title:
Non-interventional Observational Study to Evaluate Change of PSA Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide in Combination With Medical or Surgical Castration
Verified date | April 2010 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Croatia: Agency for Medicinal Product and Medical Devices |
Study type | Observational |
Prospective, non-comparative, non-interventional, observational study to collect and analyse real life environment data on advanced prostate cancer patients receiving combination treatment of medical or surgical castration and bicalutamide according to routine medical practice in Croatia. The main aim is to evaluate change of PSA level and prescribing practices based on prostate cancer stage.
Status | Completed |
Enrollment | 340 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Patients with diagnosis of advanced prostate cancer - Patients who are already treated with bicalutamide for at least 4 weeks and maximum 12 weeks - Patients capable of signing ICF Exclusion Criteria: - Patients with hypersensitivity to bicalutamide - Patients on therapy with terfenadin, astemizol or cisapride - Participation in a clinical study during the last 30 days |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Croatia | Research Site | Cakovec | |
Croatia | Research Site | Dubrovnik | |
Croatia | Research Site | Karlovac | |
Croatia | Research Site | Pula | |
Croatia | Research Site | Rijeka | |
Croatia | Research Site | Sibenik | |
Croatia | Research Site | Sisak | |
Croatia | Research Site | Slavonski brod | |
Croatia | Research Site | Split | |
Croatia | Research Site | Vinkovci | |
Croatia | Research Site | Virovitica | |
Croatia | Research Site | Vukovar | |
Croatia | Research Site | Zabok | |
Croatia | Research Site | Zadar | |
Croatia | Research Site | Zagreb |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate change in PSA level following 4-9 months of bicalutamide therapy | PSA - 2 measures (at the time of bicalutamdie introduction and 4-9 m following bicalutamide) | No | |
Secondary | bicalutamide prescribing practice based on prostate cancer stage | 1 measure (at the time of bicalutamde th introduction) | No | |
Secondary | to evaluate PSA level after 4-12 weeks of bicalutamide therapy | PSA - 1 measures (1-3 m following bicalutamide) | No | |
Secondary | to asses time to disease progression based on PSA values | PSA - 3 measures (at the time of bicalutamdie introduction, 1-3 m and 4-9 m following bicalutamide) | No | |
Secondary | to evaluate percentage of patients with disease progression | 2 measures at 1st and 2nd visit | No | |
Secondary | to evaluate withdrawals due to adverse events | 2 measures, at 1st and 2nd visit | No | |
Secondary | to evaluate withdrawals due to Croatian Institute for Health Insurance guidelines for bicalutamide prescription | 2 measures, at 1st and 2nd visit | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06006104 -
Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03936218 -
Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer
|
Phase 3 | |
Completed |
NCT02234089 -
Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.
|
||
Completed |
NCT01078545 -
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
|
N/A | |
Active, not recruiting |
NCT03511196 -
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
|
Early Phase 1 | |
Recruiting |
NCT05942001 -
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
Phase 1 | |
Active, not recruiting |
NCT04117594 -
Whole Body Magnetic Resonance Imaging Study
|
||
Not yet recruiting |
NCT06369246 -
PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer
|
Phase 2 | |
Completed |
NCT01383863 -
A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer
|
||
Completed |
NCT03651271 -
Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT05590793 -
Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
|
Phase 3 | |
Recruiting |
NCT06095089 -
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
|
Phase 1 | |
Active, not recruiting |
NCT02787837 -
PROSABI: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Abiraterone Acetate.
|
||
Active, not recruiting |
NCT02362620 -
PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.
|
||
Recruiting |
NCT05800665 -
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
|
Phase 1 | |
Recruiting |
NCT03938649 -
SRAM study_Postate Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02922218 -
PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.
|
||
Not yet recruiting |
NCT06335914 -
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
|
N/A | |
Terminated |
NCT03577028 -
Study of HPN424 in Patients With Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT03971110 -
A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.
|
Phase 4 |