Castration-resistant Prostate CancerCRPC-PNNCT03177551
Predictive Nomogram of CRPC
An observational study of Castration-resistant Prostate Cancer and Metastatic Cancer, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer, Metastatic Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2017to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants having indication and planning to receiving ADT.
Who may be able to join
- Participants who have given consent form;
- Participants with pathologically defined prostate cancer;
- Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment;
- Participants having indication and planning to receiving ADT.
Who cannot join
- Participants with previous history of ADT;
- Participants who are allergic to contrast medium;
- Participants who failed to regulate endocrine therapy with the orders requirements;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical Unversity Second Hospital
Tianjin, 300211
Rong Han, +86 022 8832 8677, miyansuo@126.com
Yuanjie Niu, MD,PhD
About this study
Official title: Development and Validation of Predictive Nomogram for Castration Resistant to Androgen Deprivation Therapy in Patients With Advanced Prostate Cancer
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine will be monitored throughout the study.
Read the detailed description
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine will be monitored throughout the study.
- Keywords
- Prostatic Neoplasms, Nomograms, Drug Resistance, Neoplasm
- Medical subject headings
- Neoplasm Metastasis, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Developement Cohort | Development the Predictive Nomogram for mCRPC in Patients with Prostate Cancer | |
| Validation Cohort | Validation the Predictive Nomogram for mCRPC in Patients with Prostate Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to castration resistant
The definition mCRPC is that the castrated androgen < 50 ng/dL or 1.7 nmol/L plus either;
- Biochemical progression: Three consecutive rises in PSA one week apart resulting in two 50% increases over the nadir, and a PSA > 2 ng/mL or,
- Radiological progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using RECIST (Response Evaluation Criteria in Solid Tumours) [736].
Symptomatic progression alone must be questioned and subject to further investigation.
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start4 May 2017
- Primary completionSep 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuanjie Niu, MD,PhD, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177551
- Sponsor's protocol ID
- CRPC-PN
- Acronym
- CRPC-PN
- Status last verified
- Sep 2018
- First submitted
- 31 May 2017
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD could be got by contacting researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Predictive Nomogram for Castration Resistant to Androgen Deprivation Therapy in Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT03177551
- Acronym / sponsor ID
- CRPC-PN / CRPC-PN
- Keywords
- Prostatic Neoplasms, Nomograms, Drug Resistance, Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine will be monitored throughout the study.
Detailed description
This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive Nomogram of metastatic castration-resistant prostate cancer (mCRPC) that will effectively predict the early onset mCRPC in patients receiving androgen-deprivation therapy (ADT). The entire duration of study will be approximately 3 year. Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving ADT based on EAU 2017 practice guideline criteria. Serum testosterone, prostate specific antigen (PSA), alkaline phosphatase (ALP) and blood routine will be monitored throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Developement Cohort | – | –Development the Predictive Nomogram for mCRPC in Patients with Prostate Cancer |
| Validation Cohort | – | –Validation the Predictive Nomogram for mCRPC in Patients with Prostate Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants having indication and planning to receiving ADT.
Key inclusion criteria (4 listed)
- Participants who have given consent form;
- Participants with pathologically defined prostate cancer;
- Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment;
- Participants having indication and planning to receiving ADT.
Key exclusion criteria (3 listed)
- Participants with previous history of ADT;
- Participants who are allergic to contrast medium;
- Participants who failed to regulate endocrine therapy with the orders requirements;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to castration resistant
Time frame: 3 YEARS
The definition mCRPC is that the castrated androgen < 50 ng/dL or 1.7 nmol/L plus either; 1. Biochemical progression: Three consecutive rises in PSA one week apart resulting in two 50% increases over the nadir, and a PSA > 2 ng/mL or, 2. Radiological progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using RECIST (Response Evaluation Criteria in Solid Tumours) [736]. Symptomatic progression alone must be questioned and subject to further investigation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: Yes. IPD could be got by contacting researchers.
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Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
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A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanjie Niu, MD,PhD principal investigator
Tianjin Medical University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Castration-resistant Prostate Cancer and Metastatic Cancer, run by Tianjin Medical University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimiao Zhu, MD,PhD (+8613752436539, zhushimiao@tijmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to castration resistant (time frame: 3 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2018.