An observational study in Prostate Cancer, Castration Resistant, sponsored by Bayer. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Bayer · Observational
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Among 75 studies in Prostatic Neoplasms by Bayer — 11 open to participants now, 16 under way, 1 of them phase 3. Prostatic Neoplasms · Bayer.
Among the 75 studies in Prostatic Neoplasms by Bayer, this one is the 30th largest by enrollment of the 40 observational ones that give a count, is one of 2 that started in 2018, is one of 40 observational ones, and was the 36th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →11 of the 75 studies in Prostatic Neoplasms by Bayer are open now, in 12 countries. Recruiting first, the newest first:
Bayer · Sites in China
Ages 18+ · Men only
Bayer · Sites in United States
Ages 55+ · Men only
Bayer · Sites in China
Ages 18+ · Men only
Bayer · Sites in Germany
Ages 18+ · Men only
Bayer · Sites in Belgium, Finland, France and 13 more countries
Ages 18+ · Men only
By country, each count listing its studies:
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
75 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 14 · Phase 3 8 · Phase 4 2
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 150 is below the median of 200 across 1,309 observational studies indexed under Prostatic Neoplasms.
Median enrollment 82 across the 34 interventional studies, 700 across the 40 observational. Of the 57 that completed or were terminated, 12 (21%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
4 of the studies in Prostatic Neoplasms by Bayer that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05794906Phase 3BayerA Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies | 2027-07-30 |
| NCT07223372BayerAn Observational Study to Learn More About How Medicines That Block Male Hormones Are Used in People With Prostate Cancer in Australia | 2026-11-30 |
| NCT07672119BayerA Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide | 2027-04-29 |
| NCT06052306BayerA Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) | 2027-06-08 |
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Among the 75 studies in Prostatic Neoplasms by Bayer, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.
The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.
The study population will be comprised of patients with CRPC and bone metastasis who have received at least one dose of radium-223 at one of the participating cancer centers. The participating centers are 4 tertiary care cancer centers (Dana Farber Cancer Institute, Tulane Cancer Center, Memorial Sloan Kettering Cancer Center and Beth Israel Deaconess Medical Center)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy
Drug: Xofigo · Drug: Taxotere · Drug: Jevtana
Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
Drug: Xofigo · Drug: Taxotere · Drug: Jevtana
Overall survival
Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).
Time frame: Up to 30 months
Time to symtomatic skeletal event(SSE)
Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
Time frame: Up to 30 months
Reasons for treatment discontinuation
data for treatment discontinuation for each mCRPC therapy will be collected
Time frame: Up to 30 months
Laboratory-based outcomes collected by questionnaire
Data will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxel
Time frame: Up to 30 months
Treatments received
measured as Yes/No
Time frame: Up to 30 months
Number of hospitalizations
along with the discharge diagnosis, as recorded in medical charts or discharge summaries
Time frame: Up to 30 months
PSA PFS
defined as death or an increase above PSA nadir by ≥25% and ≥2 ng/mL (PCWG 2008 definition for Prostate specific antigen(PSA) Progression-free survival(PFS))
Time frame: Up to 30 months
Non-laboratory based clinically relevant safety outcomes
documented in medical records
Time frame: Up to 30 months
hospital length of stay
Time frame: Up to 30 months
Ran from Dec 2018 to primary completion in Oct 2019, 10 months.
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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