An observational study in Prostatic Neoplasms, sponsored by Bayer. Completed at 1 site in Japan. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.
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 37th largest by enrollment of the 40 observational ones that give a count, is one of 2 that started in 2019, is one of 40 observational ones, and was the 34th 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: 20 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 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 85 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.
This tab as a report to print or save as PDF → With an account.
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 |
Add all 4 to your calendar (.ics) → With an account.
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.
This study aims to answer the research question: Are Japanese bone metastatic CRPC patients satisfied with their Ra-223 treatment, and what factors drive such satisfaction? It also aims to determine patient anxiety regarding prostate cancer while on treatment with Ra-223, and assess the effect on quality of life.
This is a local, Japanese, prospective, longitudinal, observational, company-sponsored, multi-center, single arm study that will describe treatment satisfaction with Ra-223 in 150 bone metastatic CRPC patients on 1st to 3rd line CRPC therapy. All outcomes will be obtained using PRO questionnaires at 4 time points: before treatment, during treatment, and at 1-month after the last treatment cycle.
Japanese CRPC patients designated to receive Ra-223 (Xofigo)
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:
Where any of the below conditions apply:
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Japanese patients who are designated to undertake Ra-223/Xofigo therapy based on physician judgement
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)
Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
The CTSQ is a 16-item self-administered questionnaire measuring 3 domains related to patients' satisfaction with cancer therapy.
Time frame: From baseline to 7 months
Change in the total scores of the CTSQ domains
Time frame: From baseline to 7 months
Change in patient anxiety with prostate cancer using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Changes in the MAX-PC scores will be analyzed as full scores (no sub-domains).
Time frame: From baseline to 7 months
Change in bone-related symptoms using the Functional Assessment of Cancer Therapy Quality of Life Measurement in Patients with Bone Pain (FACT-BP)
Change in FACT-BP scores will be analyzed as full scores (no subdomains).
Time frame: From baseline to 7 months
Differences in change in treatment satisfaction (measured by CTSQ) between potential subgroups
Potential subgroups will be identified depending on the number of patients available for subgrouping.
Time frame: From baseline to 7 months
Differences in change in prostate cancer anxiety (measured by MAX-PC) between potential subgroups
Potential subgroups will be identified depending on the number of patients available for subgrouping.
Time frame: From baseline to 7 months
Differences in change in bone pain (measured by FACT-BP) between potential subgroups
Potential subgroups will be identified depending on the number of patients available for subgrouping.
Time frame: From baseline to 7 months
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Ran from Apr 2019 to primary completion in Dec 2022, 43 months.
Of 109 industry-sponsored observational studies under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's 43 months is close to that.
Counting every sponsor, half of 649 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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