BRCA-MutatedPhase 3CaBRANCT07591467
Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
A Phase 3 study testing Experimental in people with BRCA-Mutated and Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 5 sites in France.
Trial summary
The current standard of patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) is to offer androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI). Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- BRCA-Mutated, Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer, Prostate Cancer
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2026to Dec 2036
- Phase
- Phase 3
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven adenocarcinoma of the prostate (any T stage, Gleason score or PSA level).
- De novo metastatic disease documented by a positive bone scan or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either: at least one extra-pelvic lymph node ≥ 2 cm, or extra-pelvic lymph node(s)≥1 cm if the patients also have at least one pelvic lymph node ≥ 1.5 cm.
- Presence of pathogenic BRCA gene alteration (BRCAm cohort) OR histologically adenocarcinoma of the prostate with neuroendocrine differentiation (NED cohort)
- For the BRCAm cohort: confirmation of a pathogenic BRCA gene alteration by historical analysis, using one of the following:
- Circulating tumor DNA (ctDNA) analysis
- Tumor tissue analysis (archival sample permitted)
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- Historical germline testing results
- For the NED cohort: histologically adenocarcinoma of the prostate with neuroendocrine differentiation41. NED is defined as either:
- Presence of mixed tumors with prostate adenocarcinoma associated with small cell or large cell neuroendocrine carcinoma according to WHO classification55 (5th edition). Pure small cell or large cell neuroendocrine carcinoma is not accepted (prostate adenocarcinoma component should express NKX3.1, AR and/or PSA to exclude pure small cell or large cell NE carcinoma)
- Or immunohistochemical staining showing some degree of neuroendocrine differentiation within adenocarcinoma (positivity of at least 2 of the following: chromogranin A, synaptophysin, TTF1 or INSM1). Threshold for NE markers positivity is ≥ 1% tumor cells. Co-expression of neuroendocrine markers with AR, NKX3.1 and/or PSA is allowed for these cases. If the patient has both a BRCA alteration and evidence of NED on his biopsy, he will be randomized in the BRCA cohort.
- Patients with ECOG PS ≤ 1, or patient with PS 2, provided PS alteration is disease-related.
- Life expectancy of at least 6 months.
- Male aged ≥ 18 years old and ≤ 80 years old.
- Hematology values: Hemoglobin ≥ 10.0 g/dL, Platelet count ≥ 100,000/mL, Neutrophil ≥ 1500 cells/mm³ (or neutrophil ≥ 1000 cells/mm³ in case of ethnic neutropenia).
- Biochemistry values: Renal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min, Liver function: Serum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease), AST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases), ALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal).
- Patients must have received ADT and ARPI (abiraterone, enzalutamide, apalutamide, darolutamide) for a maximum of 3 months before randomization. Prior ARPI in mHSPC is allowed if required prior to randomization, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.
- Patients willing and clinically fit to receive docetaxel with no contraindication to docetaxel according to the Summary of Product Characteristics (SmPC) of the drug.
- Patients able to take oral medication.
- Patients who have received the information sheet and signed the informed consent form
- Patients must be affiliated to a social security system or beneficiary of the same.
- Male patients who have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 6 months after the last dose of Docetaxel.
Who cannot join
- Patients with previous definitive local treatment directed to prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are allowed.
- Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer. Prior exposure to carboplatin or other platinum containing compounds.
- Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropath\>= grade 2, per the Common Terminology Criteria for Adverse Events version 6.0.
- Patients known to be human immunodeficiency virus (HIV) positive, symptomatic viral hepatitis or chronic liver disease.
- Patient with administration of live or live attenuated vaccines (strongly discouraged in patients) and is formally contraindicated in the case of the yellow fever vaccine.
- Severe or moderate hepatic impairment (Child - Pugh class C or B).
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- Clinically known significant heart disease in the past 6 months as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline, atrial fibrillation, or other cardiac arrhythmia requiring therapy.
- History of malignancy, except non-melanoma skin cancer, with low risk of recurrence within 24 months.
- Known allergies, hypersensitivity or intolerance to carboplatin or other platinum containing compounds.
- Pathological finding consistent with pure small cell carcinoma of the prostate.
- Patients already included in another therapeutic trial involving an experimental drug (patient in a non-experimental trial with no modification of the patient's care can be included).
- Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial.
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
Hôpital Saint André
Bordeaux, 33075
CLCC-Léon Bérard
Lyon, 69008
CLCC Paoli-Calmettes
Marseille, 13009
CLCC-ICL
Nancy, 54519
Gustave Roussy
Villejuif, 94805
About this study
Official title: A Phase III Randomized Trial of Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
The current standard of patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) is to offer androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI). In addition, upfront 6 cycles of docetaxel, if patient is eligible, and prostate radiotherapy for those with low-volume disease are recommended. BRCA mutations (BRCAm) and neuroendocrine differentiation (NED) confer a poor prognosis in mHSPC and the current standard of care for these patients remains suboptimal. While PARP inhibitors have shown efficacy in BRCAm castration-resistant prostate cancer, concerns exist about their toxicity and resistance when used earlier in the mHSPC setting. Carboplatin has demonstrated activity in BRCAm and neuroendocrine tumors but has not been extensively studied in mHSPC. The combination of carboplatin and docetaxel is expected to enhance treatment efficacy and delay progression.
- Conditions
- BRCA-Mutated, Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer, Prostate Cancer
- Being tested
- Experimental
- Keywords
- De novo mHSCPC, neuroendocrine differentiation, BRCA mutations (BRCAm)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDrug
Lifelong continuous ADT and darolutamide, similarly to standard of care, with the addition of docetaxel (60mg/m² per cycle) and carboplatin, with an area under the curve (AUC) of 4 mg/mL/min (AUC 4), 6 cycles + G-CSF support. For eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Lifelong continuous ADT and darolutamide, similarly to standard of care, with the addition of docetaxel (60mg/m² per cycle) and carboplatin, with an area under the curve (AUC) of 4 mg/mL/min (AUC 4), 6 cycles + G-CSF support. For eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy. Receives: Drug: Experimental |
| Control arm: Standard of care (SoC) | No intervention | Standard of care therapies consisting of lifelong ADT and continuous darolutamide, docetaxel (75 mg/m² per cycle, 6 cycles + G-CSF support) and for eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression-free survival
To demonstrate that the addition of carboplatin to SoC therapies prolongs radiographic progression-free survival in patients with de novo mHSPC harboring a BRCA gene alteration and in patients with de novo mHSCPC showing neuroendocrine differentiation. Radiographic progression is defined according to the Prostate Cancer Working Group 4 (PCWG4) criteria.
Measured: from randomization to radiographic progression or death, maximum 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA-MutatedStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Control arm: standard of care therapies consisting of lifelong ADT and continuous darolutamide, docetaxel (75 mg/m² per cycle, 6 cycles + G-CSF support) and for eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy. * Experimental arm: lifelong continuous ADT and darolutamide, similarly to standard of care, with the addition of docetaxel (60mg/m² per cycle) and carboplatin, with an area under the curve (AUC) of 4 mg/mL/min (AUC 4), 6 cycles + G-CSF support. For eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy.
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- PHRC, Ministry of Health France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591467
- Sponsor's protocol ID
- 2026-525359-10-00
- Other IDs
- CSET number 2025 / 4163
- Acronym
- CaBRA
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of Carboplatin-Enhanced Therapy in BRCA-Mutated or Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT07591467
- Acronym / sponsor ID
- CaBRA / 2026-525359-10-00
- Conditions
- BRCA-Mutated, Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer, Prostate Cancer
- Keywords
- De novo mHSCPC, neuroendocrine differentiation, BRCA mutations (BRCAm)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- PHRC, Ministry of Health France
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 15 May 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 current standard of patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) is to offer androgen deprivation therapy (ADT) with androgen receptor pathway inhibitors (ARPI). In addition, upfront 6 cycles of docetaxel, if patient is eligible, and prostate radiotherapy for those with low-volume disease are recommended. BRCA mutations (BRCAm) and neuroendocrine differentiation (NED) confer a poor prognosis in mHSPC and the current standard of care for these patients remains suboptimal. While PARP inhibitors have shown efficacy in BRCAm castration-resistant prostate cancer, concerns exist about their toxicity and resistance when used earlier in the mHSPC setting. Carboplatin has demonstrated activity in BRCAm and neuroendocrine tumors but has not been extensively studied in mHSPC. The combination of carboplatin and docetaxel is expected to enhance treatment efficacy and delay progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Control arm: standard of care therapies consisting of lifelong ADT and continuous darolutamide, docetaxel (75 mg/m² per cycle, 6 cycles + G-CSF support) and for eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy. * Experimental arm: lifelong continuous ADT and darolutamide, similarly to standard of care, with the addition of docetaxel (60mg/m² per cycle) and carboplatin, with an area under the curve (AUC) of 4 mg/mL/min (AUC 4), 6 cycles + G-CSF support. For eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: ExperimentalLifelong continuous ADT and darolutamide, similarly to standard of care, with the addition of docetaxel (60mg/m² per cycle) and carboplatin, with an area under the curve (AUC) of 4 mg/mL/min (AUC 4), 6 cycles + G-CSF support. For eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy. |
| Control arm: Standard of care (SoC) | No intervention | –Standard of care therapies consisting of lifelong ADT and continuous darolutamide, docetaxel (75 mg/m² per cycle, 6 cycles + G-CSF support) and for eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically or cytologically proven adenocarcinoma of the prostate (any T stage, Gleason score or PSA level).
- De novo metastatic disease documented by a positive bone scan or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either: at least one extra-pelvic lymph node ≥ 2 cm, or extra-pelvic lymph node(s)≥1 cm if the patients also have at least one pelvic lymph node ≥ 1.5 cm.
- Presence of pathogenic BRCA gene alteration (BRCAm cohort) OR histologically adenocarcinoma of the prostate with neuroendocrine differentiation (NED cohort)
- Patients with ECOG PS ≤ 1, or patient with PS 2, provided PS alteration is disease-related.
- Life expectancy of at least 6 months.
Key exclusion criteria (13 listed)
- Patients with previous definitive local treatment directed to prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are allowed.
- Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer. Prior exposure to carboplatin or other platinum containing compounds.
- Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropath\>= grade 2, per the Common Terminology Criteria for Adverse Events version 6.0.
- Patients known to be human immunodeficiency virus (HIV) positive, symptomatic viral hepatitis or chronic liver disease.
- Patient with administration of live or live attenuated vaccines (strongly discouraged in patients) and is formally contraindicated in the case of the yellow fever vaccine.
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 |
|---|---|---|
| ExperimentalLifelong continuous ADT and darolutamide, similarly to standard of care, with the addition of docetaxel (60mg/m² per cycle) and carboplatin, with an area under the curve (AUC) of 4 mg/mL/min (AUC 4), 6 cycles + G-CSF support. For eligible patients, prostate radiotherapy, at least 3 weeks after the completion of chemotherapy. | Drug | Experimental arm |
Primary outcome
Radiographic progression-free survival
Time frame: from randomization to radiographic progression or death, maximum 10 years
To demonstrate that the addition of carboplatin to SoC therapies prolongs radiographic progression-free survival in patients with de novo mHSPC harboring a BRCA gene alteration and in patients with de novo mHSCPC showing neuroendocrine differentiation. Radiographic progression is defined according to the Prostate Cancer Working Group 4 (PCWG4) criteria.
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 15 May 2026.
- Individual participant dataSharing planned: Yes
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental in people with BRCA-Mutated and Neuroendocrine-Differentiated Aggressive Metastatic Castration-Sensitive Prostate Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 5 sites in France.
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 21 inclusion and 13 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alice BERNARD-TESSIER, MD. (+ 33(0)1 42 11 64 44, ALICE.BERNARD-TESSIER@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic progression-free survival (time frame: from randomization to radiographic progression or death, maximum 10 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 15 May 2026.