Metastatic Castration-resistant Prostate CancerPROceedNCT06380738
Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)
An observational study of Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 36 sites in Germany.
Trial summary
PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- How many people
- 111 participants
- Where
- 36 sitesGermany
- Study dates
- 14 Feb 2024to 14 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 patients with a confirmed mCRPC diagnosis that has initiated the combination of olaparib and abiraterone through routine clinical practice at participating sites in Germany.
Who may be able to join
- Willing and able to provide written informed consent;
- 18 years of age and above;
- Documented histopathology or cytopathology of PCa, adenocarcinoma;
- Confirmed as mCRPC;
- Initiated olaparib + abiraterone after site activation
Who cannot join
- Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Germany36 sites
Research Site
Aschaffenburg
Research Site
Augsburg
Research Site
Bergisch Gladbach
Research Site
Berlin
Research Site
Bonn
Research Site
Cologne
Research Site
Dresden
Research Site
Duisburg
Research Site
Eisenach
Research Site
Eisleben Lutherstadt
Research Site
Frankfurt
Research Site
Greifswald
Research Site
Halle
Research Site
Hamburg
Research Site
Hanover
Research Site
Heidelberg
Research Site
Heinsberg
Research Site
Herzogenaurach
Research Site
Leipzig
Research Site
Lichtenfels
Research Site
Lübeck
Research Site
Lüneburg
Research Site
Magdeburg
Research Site
Marburg
Research Site
Mülheim
Research Site
Münster
Research Site
Nuremberg
Research Site
Rüsselsheim am Main
Research Site
Saalfeld
Research Site
Speyer
Research Site
Trier
Research Site
Tübingen
Research Site
Westerstede
Research Site
Wetzlar
Research Site
Winnenden
Research Site
Wuppertal
About this study
Official title: A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone
PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment discontinuation
Time to treatment discontinuation (TTD) event-free rate at 6 months and 12 months will be assessed among patients treated with olaparib + abiraterone in 1L mCRPC setting by prior NHA exposure status (NHA-exposed and NHA-naive), respectively.
TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause.
Measured: Up to 12 months
Secondary outcomes (1)
Time to first subsequent therapy
Time to first subsequent therapy (TFST) in mCRPC patients treated with olaparib + abiraterone.
TFST is defined as the time from olaparib initiation to the earlier of the first subsequent anticancer therapy start date following olaparib discontinuation or death due to any cause.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start14 Feb 2024
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380738
- Sponsor's protocol ID
- D0817R00074
- Other IDs
- D0817R00074
- Acronym
- PROceed
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate Real-world Clinical Outcomes and Characteristics of Patients With mCRPC Treated With Olaparib + Abiraterone
- ClinicalTrials.gov ID
- NCT06380738
- Acronym / sponsor ID
- PROceed / D0817R00074
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 24 Apr 2024 (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.
PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 patients with a confirmed mCRPC diagnosis that has initiated the combination of olaparib and abiraterone through routine clinical practice at participating sites in Germany.
Key inclusion criteria (5 listed)
- Willing and able to provide written informed consent;
- 18 years of age and above;
- Documented histopathology or cytopathology of PCa, adenocarcinoma;
- Confirmed as mCRPC;
- Initiated olaparib + abiraterone after site activation
Key exclusion criteria (1 listed)
- Patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation
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 treatment discontinuation
Time frame: Up to 12 months
Time to treatment discontinuation (TTD) event-free rate at 6 months and 12 months will be assessed among patients treated with olaparib + abiraterone in 1L mCRPC setting by prior NHA exposure status (NHA-exposed and NHA-naive), respectively. TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause.
1 secondary outcome
Time to first subsequent therapy
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Related trials for Metastatic Castration-resistant Prostate Cancer
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
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 36 sites 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to treatment discontinuation (time frame: Up to 12 months). 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 16 Sep 2026.