Trial · NCT05701007
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
NCT05701007, Completed, Pfizer; results first posted 2026-01-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland. Trials, record NCT05701007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05701007
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
- NCT number
- NCT05701007
- Status
- Completed
- Enrollment
- 1,083 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration Resistant Prostate Cancer (mCRPC)
- Interventions
- abiraterone, enzalutamide, docetaxel, apalutamide, cabazitaxel, Radium-223, Lutetium-177, degarelix, goserelin, leuprorelin, triptorelin
- First posted
- 2023-01-26
- Last updated
- 2026-01-29
- Results first posted
- 2026-01-29
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Body Mass Index (BMI) | 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months | BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass. It is widely used as a general indicator of whether a participant has a healthy body weight for their height. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
| Primary | Prostate-Specific Antigen (PSA) | 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months | PSA is a protein produced by the prostate gland, and the PSA test measures its levels in the blood. It is primarily used to screen for prostate cancer and monitor participants after treatment. Elevated PSA levels may indicate prostate cancer or other prostate abnormalities. Common prostate abnormalities include benign prostatic hyperplasia, prostatitis, prostate cancer. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
| Primary | Alkaline Phosphatase (P-AFOS) | 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months | Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
| Primary | Length of Follow-up | From index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
| Primary | Number of Participants With de Novo Metastasis | Within 2 months from index date; retrospective available data evaluated in this study for approximately 14 months | The new metastasis was defined based on the prostate cancer diagnosis dates within 2 months from the index date. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to metastatic castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered new CRPC). |
| Primary | Number of Participants Who Received Treatment for mCRPC and mCSPC | Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Number of participants who received treatment for mCRPC and mCSPC were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
| Primary | Number of Participants Diagnosed With mCSPC Who Progressed to mCRPC | Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Number of participants initially diagnosed With mCSPC who progressed into mCRPC were reported in this outcome measure. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
| Primary | Number of Participants With Orchiectomy | Closest record any time from index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Number of participants with orchiectomy done were reported in this outcome measure. Orchiectomy is a surgical procedure in which one or both testicles are removed. It is commonly performed to treat or prevent prostate cancer from spreading. Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
| Primary | Number of Participants Undergone Palliative Radiology | Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Number of participants with palliative radiology done were reported in this outcome measure. This is a treatment designed to alleviate symptoms caused by advanced cancer, rather than cure the disease. It is commonly used to reduce tumor size or provide relief from pain, bleeding, or obstructions, ultimately enhancing the participant's quality of life. It is especially beneficial for participants with cancers that cannot be cured, offering relief from distressing symptoms such as tumor compression on organs or bones, as well as severe pain. Palliative radiology is analyzed based on procedure code (WF049). Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
| Primary | Number of Participants With Symptomatic Skeletal-Related Event (SSRE) | Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | SSRE was defined as bone instability related to the treatment of advanced prostate cancer or due to the spread of prostate cancer to the bone (metastases). Index date for (i) mCSPC participants were defined as date for the first record of mPC (ii) mCRPC participants were defined as date for progression to castration resistant (if =3 months from castration-sensitive treatment initiation \[1st control usually at 3 months\], considered de novo CRPC). |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Body Mass Index (BMI) | 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Analysis excluded participants with missing data. | Kilogram per meter square | MEAN |
| PRIMARY | Prostate-Specific Antigen (PSA) | 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Analysis excluded participants with missing data. | Nanogram per milliliter | MEAN |
| PRIMARY | Alkaline Phosphatase (P-AFOS) | 3 months before index date (closest value); retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Analysis excluded participants with missing data. | Units per liter | MEAN |
| PRIMARY | Length of Follow-up | From index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. | Years | MEAN |
| PRIMARY | Number of Participants With de Novo Metastasis | Within 2 months from index date; retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Received Treatment for mCRPC and mCSPC | Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Diagnosed With mCSPC Who Progressed to mCRPC | Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. Only reporting arm Participants Diagnosed With mCSPC is reported as this outcome measure was to be analyzed for participants who had mCSPC and they progressed to mCRPC. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Orchiectomy | Closest record any time from index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Undergone Palliative Radiology | Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Symptomatic Skeletal-Related Event (SSRE) | Post index date to end of follow-up date [death or end of identification 31-Dec-2022, whichever occurred first], maximum up to approx.9 years; retrospective available data evaluated in this study for approximately 14 months | Analysis population included all eligible participants whose data were included and observed for evaluation in the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group242
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Body Mass Index (BMI) | Participants Diagnosed With mCSPC | 27.9 | Standard Deviation 12.4 | Kilogram per meter square | |
| Body Mass Index (BMI) | Participants Diagnosed With mCRPC | 27.1 | Standard Deviation 4.7 | Kilogram per meter square | |
| Prostate-Specific Antigen (PSA) | Participants Diagnosed With mCSPC | 199.7 | Standard Deviation 704.7 | Nanogram per milliliter | |
| Prostate-Specific Antigen (PSA) | Participants Diagnosed With mCRPC | 92 | Standard Deviation 396.4 | Nanogram per milliliter | |
| Alkaline Phosphatase (P-AFOS) | Participants Diagnosed With mCSPC | 214.1 | Standard Deviation 402.3 | Units per liter | |
| Alkaline Phosphatase (P-AFOS) | Participants Diagnosed With mCRPC | 144 | Standard Deviation 221.8 | Units per liter | |
| Length of Follow-up | Participants Diagnosed With mCSPC | 1.8 | Standard Deviation 1.8 | Years | |
| Length of Follow-up | Participants Diagnosed With mCRPC | 1.9 | Standard Deviation 1.6 | Years | |
| Number of Participants With de Novo Metastasis | Participants Diagnosed With mCSPC | 444 | Participants | ||
| Number of Participants With de Novo Metastasis | Participants Diagnosed With mCRPC | 240 | Participants |
1 to 10 of 242Source ClinicalTrials.gov
See all 242 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Diagnosed With mPC | 1,083 | |
| Overall Study | Participants Diagnosed With mCSPC | Participants Diagnosed With mPC | 795 | |
| Overall Study | Participants Diagnosed With mCRPC | Participants Diagnosed With mPC | 558 | |
| Overall Study | COMPLETED | Participants Diagnosed With mPC | 1,083 | |
| Overall Study | NOT COMPLETED | Participants Diagnosed With mPC | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Diagnosed With mCSPC | 343 | 795 |
| Total, all-cause mortality | Participants Diagnosed With mCRPC | 218 | 558 |
| Total, other adverse events | Participants Diagnosed With mCSPC | 0 | 0 |
| Total, other adverse events | Participants Diagnosed With mCRPC | 0 | 0 |
| Total, serious adverse events | Participants Diagnosed With mCSPC | 0 | 0 |
| Total, serious adverse events | Participants Diagnosed With mCRPC | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42221687 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Participants Diagnosed With mCSPC vs Participants Diagnosed With mCRPC: Number of Participants Who Received Treatment for mCRPC and mCSPC | Trial comparisons |
| Participants Diagnosed With mCSPC vs Participants Diagnosed With mCRPC: Number of Participants With Symptomatic Skeletal-Related Event (SSRE) | Trial comparisons |
| Participants Diagnosed With mCSPC vs Participants Diagnosed With mCRPC: Number of Participants With Orchiectomy | Trial comparisons |
| Participants Diagnosed With mCSPC vs Participants Diagnosed With mCRPC: Number of Participants With de Novo Metastasis | Trial comparisons |
| Participants Diagnosed With mCSPC vs Participants Diagnosed With mCRPC: Number of Participants Who Were on Opioids | Trial comparisons |
| Participants Diagnosed With mCSPC vs Participants Diagnosed With mCRPC: Number of Participants Undergone Palliative Radiology | Trial comparisons |
| Participants Diagnosed With mCSPC vs Participants Diagnosed With mCRPC: Number of Participants Who Were on Bone Medication | Trial comparisons |
| Participants Diagnosed With mCSPC vs Participants Diagnosed With mCRPC: deaths from any cause | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05701007
GET https://conductscience.org/api/trials/v1/NCT05701007/registered?page=2