Second Primary Cancers in Patients With Castration Resistant Prostate Cancer

An observational study of Prostatic Neoplasms, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims at estimating the incidence of second primary malignancies as well as the overall survival among metastasized prostate cancer (mPC) and metastasized castrate-resistant prostate cancer (mCRPC) patients not treated with radium-223-dichloride. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostatic Neoplasms
How many people: 6,442 participants
Where: 1 siteGermany
Study dates: 15 Mar 2016to 20 Oct 2017
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: The study population will consist of mPC patients (prostate cancer patients with bone metastases) and a subgroup of patients who can be regarded as mCRPC patients (castration-resistant prostate cancer patients with bone metastases).

Who may be able to join

Members of the mPC cohort will have to fulfill all of the following criteria:
Valid information on sex, age and the region of residence
A period of at least 12 months of continuous insurance preceding cohort entry
Diagnosis of PC (ICD-10 Code C61) in the study period (01-Jan-2004 to 31-Dec-2011)
Diagnosis of bone metastases (ICD-10 Code C79.5) in the enrolment period (01-Jan-2005 to 31-Dec-2011)
In addition to the criteria of the mPC cohort, members of the mCRPC will additionally have to fulfill:

Show all 10Show fewer

One of the following in the enrolment period and before or at the same time with bone metastases
Discontinuation of the initial chemical castration, change of the agent or modality of the Androgen deprivation therapy (ADT), or start of treatment for advanced Prostate cancer (PC) after the primary ADT.
Surgical castration and initiation of ADT treatment
Treatment with medication specific to mCRPC.

Who cannot join

Patients will be excluded from the mPC and from the mCRPC populations if they meet one of the following criteria:
First PC diagnosis later than 2 months after the diagnosis of bone metastases, or
Use of any radiopharmaceuticals for bone metastases (e.g., samarium, strontium, rhenium, radium)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Multiple Locations

Other trials in Germany

About this study

Official title: Second Primary Cancers in Patients With Castration Resistant Prostate Cancer (BOCARP)

Read the detailed description

This study aims at estimating the incidence of second primary malignancies as well as the overall survival among mPC and mCRPC patients not treated with radium-223-dichloride. The source of data for this study will be the German Pharmacoepidemiological Research Database (GePaRD). A retrospective cohort study covering the time period from 2004 to 2013 will be conducted. The study population will comprise CRPC patients developing bone metastases. These patients will be followed up for the occurrence of second primary malignancies, end of study, or death due to any cause. As this study serves as a historical control group for a single-arm observational study, incidence rates of second primary malignancies obtained from these studies will be compared by the standardized incidence ratio using results from this study as a reference.

Conditions: Prostatic Neoplasms
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Other
Historical Reference group.

Study groups in NCT02702908
Study group	Role	What they receive
mPC		Prostate cancer patients with bone metastases (mPC)
mCRPC		Patients with castration-resistant prostate cancer with bone metastases (mCRPC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidences of Second primary malignancies are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
Measured: Up to 10 years

Secondary outcomes (1)

Overall survival
Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201620 Oct 2017

First posted9 Mar 2016 (estimated)
Study start15 Mar 2016
Primary completion20 Oct 2017
Study completion20 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
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: Retrospective
Enrolment: 6,442 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02702908
Sponsor's protocol ID: 18044
Other IDs: EUPAS12665
Acronym: BOCARP
Status last verified: Jan 2018
First submitted: 4 Mar 2016
Last updated: 19 Jan 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Second Primary Cancers in Patients With Castration Resistant Prostate Cancer (BOCARP)
ClinicalTrials.gov ID: NCT02702908
Acronym / sponsor ID: BOCARP / 18044
Conditions: Prostatic Neoplasms
Study type: Observational
Recruitment status: Completed
Enrolment: 6,442 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 15 Mar 2016 (actual)
Primary completion: 20 Oct 2017 (actual)
Study completion: 20 Oct 2017 (actual)
First posted: 9 Mar 2016 (estimated)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
mPC	–	–Prostate cancer patients with bone metastases (mPC)
mCRPC	–	–Patients with castration-resistant prostate cancer with bone metastases (mCRPC)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will consist of mPC patients (prostate cancer patients with bone metastases) and a subgroup of patients who can be regarded as mCRPC patients (castration-resistant prostate cancer patients with bone metastases).

Key inclusion criteria (10 listed)

Members of the mPC cohort will have to fulfill all of the following criteria:

Key exclusion criteria (3 listed)

Patients will be excluded from the mPC and from the mCRPC populations if they meet one of the following criteria:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Historical Reference group.	Other	mCRPC, mPC

Primary outcome

Incidences of Second primary malignancies are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
Time frame: Up to 10 years

1 secondary outcome

Overall survival
Time frame: Up to 10 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.

Related trials for Prostatic Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

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.

Bayer Study Director study director

Bayer

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 Prostatic Neoplasms, run by Bayer at 1 site in Germany.

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 10 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: finished, as of the sponsor's last update on 19 Jan 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidences of Second primary malignancies are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48. (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02702908.

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 19 Jan 2018.