Metastatic Castration-resistant Prostate Cancer (mCRPC)PROLONGNCT07674121
PROLONG (PRostateOLaparibONcombinationGcc) Study
An observational study of Metastatic Castration-resistant Prostate Cancer (mCRPC), run by AstraZeneca.
Trial summary
The study will generate regionally relevant data to inform clinical practice, support treatment guidelines, and potentially contribute to supportive evidence for health authority discussions or scientific publications. 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 (mCRPC)
- What is being tested?
- Olaparib and Abiraterone Combination
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Sep 2029
- 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 adult male patients (≥18 years) diagnosed with mCRPC who initiate first-line treatment with Olaparib in combination with Abiraterone in routine clinical practice.
Who may be able to join
- Adult male patients (age ≥18 years)
- Documented histopathology or cytopathology of metastatic prostate adenocarcinoma
- Confirmed castration-resistant status, defined as disease progression despite castrate levels of serum testosterone (<50 ng/dL or <1.7 nmol/L), as demonstrated by radiographic progression, PSA progression, or symptomatic progression
- Prior exposure to an NHA in earlier settings.
- Planned or prior initiation of Olaparib + Abiraterone in the 1st line mCRPC setting as per routine clinical practice.
- Patients who are willing and able to sign an informed consent and are either currently receiving or are planned to initiate Olaparib + Abiraterone per routine clinical practice.
Who cannot join
- -Prior exposure to a Poly (ADP-ribose) Polymerase Inhibitor (PARPi), including Olaparib, Rucaparib, Niraparib, or Talazoparib.
- Patients who received or progressed on abiraterone in previous lines of treatment before mCRPC diagnosis (e.g., in metastatic hormone-sensitive prostate cancer [mHSPC]).
- Participation in an investigational clinical trial with another prostate cancer therapy within 30 days prior to Olaparib initiation.
- Life expectancy <3 months (unrelated to mCRPC) that could interfere with study outcomes
- Known hypersensitivity to Olaparib, Abiraterone, or their excipients.
- Uncontrolled medical conditions that may compromise participation or data interpretation, in the opinion of the Investigator (e.g., severe hepatic impairment, active infections).
- Any psychiatric or cognitive conditions that may interfere with the patient's ability to consent or comply with study procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: Non-Interventional, Observational, Retrospective and Prospective, Single- Arm Study to Assess the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA Pre-exposed mCRPC Patients in the GCC Region
The study will generate regionally relevant data to inform clinical practice, support treatment guidelines, and potentially contribute to supportive evidence for health authority discussions or scientific publications. This aligns with AstraZeneca's strategic goal of expanding the real-world evidence (RWE) base for Olaparib in diverse populations and practice settings. The study also complements the strategic priorities and focus areas, as well as strengthening AstraZeneca's leadership position in the management of prostate cancer and establishing the intensification therapy of Poly (ADP-ribose) Polymerase Inhibitor (PARPi) combination in metastatic castration-resistant prostate cancer (mCRPC) with previous exposure to a novel hormonal agent (NHA) for current and future medications (a next-generation PARPi).
- Being tested
- Olaparib and Abiraterone Combination
- Keywords
- Prostate Cancer, Olaparib and Abiraterone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib and Abiraterone CombinationDrug
Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients
| Study group | Role | What they receive |
|---|---|---|
| Prospective Pathway | Enrollment of eligible patients with NHA pre-exposed mCRPC initiating first-line Olaparib + Abiraterone at the time of consent, and were scheduled to start treatment in routine clinical practice. Primary Follow-Up Period (12 months) and Exploratory Follow-Up Period (optional, up to 12 additional months) Receives: Drug: Olaparib and Abiraterone Combination | |
| Retrospective Pathway | Enrollment of eligible patients with NHA pre-exposed mCRPC who had initiated first-line Olaparib + Abiraterone in routine clinical practice and had already discontinued the regimen prior to enrollment. Clinical data will be collected retrospectively from the index date (treatment initiation) through treatment discontinuation and up to baseline from electronic medical records (EMRs). No prospective follow up beyond baseline is planned for this pathway. Receives: Drug: Olaparib and Abiraterone Combination | |
| Ambispective Pathway | Enrollment of eligible patients with NHA pre-exposed mCRPC who had already initiated first-line Olaparib + Abiraterone in routine clinical practice up to 12 months before baseline and consent. Primary Follow-Up Period (12 months) and Exploratory Follow-Up Period (optional, up to 12 additional months) Receives: Drug: Olaparib and Abiraterone Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months in 1L NHA pre-exposed mCRPC patients treated with Olaparib + Abiraterone.
Time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months of treatment, defined as the time from initiation of Olaparib + Abiraterone therapy (index date) until the end date of therapy or death due to any cause.
Measured: 6 and 12 months
Secondary outcomes (15)
Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.
Time to first subsequent therapy (TFST), defined as the time from Olaparib + Abiraterone therapy (index date) initiation to the earlier of the first subsequent anticancer therapy start date following olaparib discontinuation due to any cause.
Measured: 12 months
Describe patient demographics: age in years
Patient demographics: age collected in years
Measured: Collected at Baseline on the day of the first patient visit
Describe patient demographics: sex
Patient demographics: sex collected as male or female
Measured: Collected at Baseline on the day of the first patient visit
Describe patient demographics: Body mass index (BMI)
Patient demographics: Body mass index (BMI) collected in kg/m 2
Measured: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Gleason score
Patient Gleason score
Measured: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Eastern Cooperative Oncology Group (ECOG) performance status
Patient Eastern Cooperative Oncology Group (ECOG) performance status
Measured: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: metastasis site(s) at baseline
metastasis site(s) at baseline
Measured: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Homologous Recombination Repair (HRR) mutation status
Patient Homologous Recombination Repair (HRR) mutation status
Measured: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Breast Cancer Gene (BRCA) mutation status
Patient Breast Cancer Gene (BRCA) mutation status
Measured: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: baseline serum PSA
Patient baseline serum PSA
Measured: Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination: Duration of previous therapies
Describe the Duration of previous therapies by collecting start and end date
Measured: Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).
Descriptive characterization of prior treatment patterns, including: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).
Measured: Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination.
- Descriptive characterization of prior treatment patterns, including: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).
- Duration of previous therapies.
Measured: Collected at Baseline on the day of the first patient visit
Assess real-world progression free survival (rwPFS) using data collected at 12 months.
- Real-world progression-free survival (rwPFS), defined as the time from initiation of Olaparib + Abiraterone therapy (index date) until the earliest record of disease progression or death due to any cause, with progression determined as per routine practice, by physicians' assessments.
Measured: 12 months
Assess real-world progression free survival (rwPFS) using data collected at 12 months.
description of progression will be collected,
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (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 Cancer (mCRPC)Studies 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
- Other
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674121
- Sponsor's protocol ID
- D0817R00131
- Acronym
- PROLONG
- Status last verified
- May 2026
- First submitted
- 9 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional, Observational, Retrospective and Prospective, Single- Arm Study to Assess the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA Pre-exposed mCRPC Patients in the GCC Region
- ClinicalTrials.gov ID
- NCT07674121
- Acronym / sponsor ID
- PROLONG / D0817R00131
- Keywords
- Prostate Cancer, Olaparib and Abiraterone
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 29 Jun 2026 (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.
The study will generate regionally relevant data to inform clinical practice, support treatment guidelines, and potentially contribute to supportive evidence for health authority discussions or scientific publications. This aligns with AstraZeneca's strategic goal of expanding the real-world evidence (RWE) base for Olaparib in diverse populations and practice settings. The study also complements the strategic priorities and focus areas, as well as strengthening AstraZeneca's leadership position in the management of prostate cancer and establishing the intensification therapy of Poly (ADP-ribose) Polymerase Inhibitor (PARPi) combination in metastatic castration-resistant prostate cancer (mCRPC) with previous exposure to a novel hormonal agent (NHA) for current and future medications (a next-generation PARPi).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective Pathway | – | Drug: Olaparib and Abiraterone CombinationEnrollment of eligible patients with NHA pre-exposed mCRPC initiating first-line Olaparib + Abiraterone at the time of consent, and were scheduled to start treatment in routine clinical practice. Primary Follow-Up Period (12 months) and Exploratory Follow-Up Period (optional, up to 12 additional months) |
| Retrospective Pathway | – | Drug: Olaparib and Abiraterone CombinationEnrollment of eligible patients with NHA pre-exposed mCRPC who had initiated first-line Olaparib + Abiraterone in routine clinical practice and had already discontinued the regimen prior to enrollment. Clinical data will be collected retrospectively from the index date (treatment initiation) through treatment discontinuation and up to baseline from electronic medical records (EMRs). No prospective follow up beyond baseline is planned for this pathway. |
| Ambispective Pathway | – | Drug: Olaparib and Abiraterone CombinationEnrollment of eligible patients with NHA pre-exposed mCRPC who had already initiated first-line Olaparib + Abiraterone in routine clinical practice up to 12 months before baseline and consent. Primary Follow-Up Period (12 months) and Exploratory Follow-Up Period (optional, up to 12 additional months) |
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 adult male patients (≥18 years) diagnosed with mCRPC who initiate first-line treatment with Olaparib in combination with Abiraterone in routine clinical practice.
Key inclusion criteria (6 listed)
- Adult male patients (age ≥18 years)
- Documented histopathology or cytopathology of metastatic prostate adenocarcinoma
- Confirmed castration-resistant status, defined as disease progression despite castrate levels of serum testosterone (<50 ng/dL or <1.7 nmol/L), as demonstrated by radiographic progression, PSA progression, or symptomatic progression
- Prior exposure to an NHA in earlier settings.
- Planned or prior initiation of Olaparib + Abiraterone in the 1st line mCRPC setting as per routine clinical practice.
Key exclusion criteria (7 listed)
- -Prior exposure to a Poly (ADP-ribose) Polymerase Inhibitor (PARPi), including Olaparib, Rucaparib, Niraparib, or Talazoparib.
- Patients who received or progressed on abiraterone in previous lines of treatment before mCRPC diagnosis (e.g., in metastatic hormone-sensitive prostate cancer [mHSPC]).
- Participation in an investigational clinical trial with another prostate cancer therapy within 30 days prior to Olaparib initiation.
- Life expectancy <3 months (unrelated to mCRPC) that could interfere with study outcomes
- Known hypersensitivity to Olaparib, Abiraterone, or their excipients.
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 |
|---|---|---|
| Olaparib and Abiraterone CombinationObserving the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients | Drug | Ambispective Pathway, Prospective Pathway, Retrospective Pathway |
Primary outcome
Evaluate the time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months in 1L NHA pre-exposed mCRPC patients treated with Olaparib + Abiraterone.
Time frame: 6 and 12 months
Time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months of treatment, defined as the time from initiation of Olaparib + Abiraterone therapy (index date) until the end date of therapy or death due to any cause.
15 secondary outcomes
Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.
Time frame: 12 months
Describe patient demographics: age in years
Time frame: Collected at Baseline on the day of the first patient visit
Describe patient demographics: sex
Time frame: Collected at Baseline on the day of the first patient visit
Describe patient demographics: Body mass index (BMI)
Time frame: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Gleason score
Time frame: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: metastasis site(s) at baseline
Time frame: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Homologous Recombination Repair (HRR) mutation status
Time frame: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Breast Cancer Gene (BRCA) mutation status
Time frame: Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: baseline serum PSA
Time frame: Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination: Duration of previous therapies
Time frame: Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).
Time frame: Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination.
Time frame: Collected at Baseline on the day of the first patient visit
Assess real-world progression free survival (rwPFS) using data collected at 12 months.
Time frame: 12 months
Assess real-world progression free survival (rwPFS) using data collected at 12 months.
Time frame: 12 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 29 Jun 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 shared.
Related trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
Active, not recruitingPhase 1
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 1
A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
RecruitingEarly Phase 1
Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy
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.
AstraZeneca Clinical Study Information Center contact
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostate Cancer (mCRPC), run by AstraZeneca.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months in 1L NHA pre-exposed mCRPC patients treated with Olaparib + Abiraterone. (time frame: 6 and 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 29 Jun 2026.