Castration-resistant Prostate CancerPhase 2PRO-CARBONCT03652493
Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
A Phase 2 study testing Carboplatin in people with Castration-resistant Prostate Cancer and Metastasis, run by Centre Francois Baclesse at 4 sites in France.
Trial summary
The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway. 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, Metastasis
- What is being tested?
- Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Sep 2018to 21 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients > 18 years old
- Patients with adenocarcinoma or poorly differentiated prostate carcinoma, histologically confirmed (small-cell histology or high-grade neuroendocrine histology excluded)
- Tumor presenting a somatic pathogenic variant likely to alter the homologous recombination pathway previously detected on a tumor biopsy or on circulating tumor DNA, or germinal mutation among the list of genes defined in the study
- Castration-resistant tumor defined by progression despite well-conducted androgen deprivation treatment: testosterone ≤50ng /dL agonist / antagonist of luteinizing hormone-releasing hormone (LHRH) or surgical castration. The patient must agree to continue concomitant LHRH-mediated (agonist or antagonist) therapy throughout the duration of the study regimen for patients with no history of surgical castration.
- Patients must have performed at least one line of chemotherapy by taxane in case of castration resistance:
- Patients who have received docetaxel treatment in a hormone-sensitive situation must have received at least treatment with cabazitaxel in case of castration resistance
Show all 11Show fewer
- Patients who have not received chemotherapy in a hormone-sensitive situation must have received docetaxel AND cabazitaxel or have a contraindication to discontinue treatment.
- Patients must have been treated with at least 2nd generation hormone therapy (eg, abiraterone acetate or enzalutamide)
- Patients may have been treated with a poly (ADP-ribose) polymerase inhibitor (PARP)
- Performance Status <2
- Metastatic disease progressive
Who cannot join
- Absence of previous treatment with taxane in situation of sensitivity or resistance to castration.
- Absence of previous treatment with cabazitaxel in case of resistance to castration (except contraindication explaining the non-administration of treatment)
- No treatment with 2nd generation hormone therapy (eg abiraterone acetate or enzalutamide) unless contraindicated to explain non-administration of treatment
- Previous treatment with platinum
- Symptomatic and untreated central nervous system (CNS) metastases. Patients with asymptomatic and pre-treated CNS metastases are included if they are clinically stable (not requiring corticosteroid therapy for 28 days) and must have a brain MRI evaluation at screening and during follow-up.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre François Baclesse
Caen, 14076
Centre Oscar Lambret
Lille, 59000
Chu Rouen
Rouen, 76000
Institut Gustave ROUSSy IGR
Villejuif
About this study
Official title: Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway.
This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response
- Conditions
- Castration-resistant Prostate Cancer, Metastasis
- Being tested
- Carboplatin
- Keywords
- Anomaly of the Homologous Recombination (HR) pathway, Carboplatin
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Tumoral evaluation every 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| CARBOPLATIN | Experimental | CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Carboplatin on Metastatic Prostatic Carcinoma Resistant to Castration Efficacy of Carboplatin: The Best Radiological Tumoral Response Rate
Tumoral response rate (TR) defined according to the recommendations of the PCWG3 criteria : Objective radiological response
Measured: Up to 27 weeks (9 cycles)
Efficacy of Carboplatin: Biological Response Rate Defined by Value of PSA
Biological response rate (TR) defined according to the recommendations of the PCWG3 criteria : Decrease of PSA ≥ 50%,
Measured: Up to 27 weeks (9 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start10 Sep 2018
- Primary completion27 Apr 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- French Interregional Group of Clinical Research and Innovation, Ligue contre le cancer, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652493
- Sponsor's protocol ID
- 2017-004764-35
- Other IDs
- 2017
- Acronym
- PRO-CARBO
- Status last verified
- May 2026
- First submitted
- 25 Jul 2018
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coquan E, Penel N, Lequesne J, Leman R, Lavaud P, Neviere Z, Brachet PE, Meriaux E, Carnot A, Boutrois J, Castera M, Goardon N, Muller E, Leconte A, Thiery-Vuillemin A, Clarisse B, Joly F. Carboplatin in metastatic castration-resistant prostate cancer patients with molecular alterations of the DNA damage repair pathway: the PRO-CARBO phase II trial. Ther Adv Urol. 2024 Feb 28;16:17562872241229876. doi: 10.1177/17562872241229876. eCollection 2024 Jan-Dec.
PubMed 38425504
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway
- ClinicalTrials.gov ID
- NCT03652493
- Acronym / sponsor ID
- PRO-CARBO / 2017-004764-35
- Conditions
- Castration-resistant Prostate Cancer, Metastasis
- Keywords
- Anomaly of the Homologous Recombination (HR) pathway, Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- French Interregional Group of Clinical Research and Innovation, Ligue contre le cancer, France
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 11 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway.
This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CARBOPLATIN | Experimental | Drug: CarboplatinCARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients > 18 years old
- Patients with adenocarcinoma or poorly differentiated prostate carcinoma, histologically confirmed (small-cell histology or high-grade neuroendocrine histology excluded)
- Tumor presenting a somatic pathogenic variant likely to alter the homologous recombination pathway previously detected on a tumor biopsy or on circulating tumor DNA, or germinal mutation among the list of genes defined in the study
- Castration-resistant tumor defined by progression despite well-conducted androgen deprivation treatment: testosterone ≤50ng /dL agonist / antagonist of luteinizing hormone-releasing hormone (LHRH) or surgical castration. The patient must agree to continue concomitant LHRH-mediated (agonist or antagonist) therapy throughout the duration of the study regimen for patients with no history of surgical castration.
- Patients must have performed at least one line of chemotherapy by taxane in case of castration resistance:
Key exclusion criteria (5 listed)
- Absence of previous treatment with taxane in situation of sensitivity or resistance to castration.
- Absence of previous treatment with cabazitaxel in case of resistance to castration (except contraindication explaining the non-administration of treatment)
- No treatment with 2nd generation hormone therapy (eg abiraterone acetate or enzalutamide) unless contraindicated to explain non-administration of treatment
- Previous treatment with platinum
- Symptomatic and untreated central nervous system (CNS) metastases. Patients with asymptomatic and pre-treated CNS metastases are included if they are clinically stable (not requiring corticosteroid therapy for 28 days) and must have a brain MRI evaluation at screening and during follow-up.
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 |
|---|---|---|
| CarboplatinTumoral evaluation every 3 cycles | Drug | CARBOPLATIN |
Primary outcome
Efficacy of Carboplatin on Metastatic Prostatic Carcinoma Resistant to Castration Efficacy of Carboplatin: The Best Radiological Tumoral Response Rate
Time frame: Up to 27 weeks (9 cycles)
Tumoral response rate (TR) defined according to the recommendations of the PCWG3 criteria : Objective radiological response
Efficacy of Carboplatin: Biological Response Rate Defined by Value of PSA
Time frame: Up to 27 weeks (9 cycles)
Biological response rate (TR) defined according to the recommendations of the PCWG3 criteria : Decrease of PSA ≥ 50%,
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38425504Coquan E, Penel N, Lequesne J, Leman R, Lavaud P, Neviere Z, Brachet PE, Meriaux E, Carnot A, Boutrois J, Castera M, Goardon N, Muller E, Leconte A, Thiery-Vuillemin A, Clarisse B, Joly F. Carboplatin in metastatic castration-resistant prostate cancer patients with molecular alterations of the DNA damage repair pathway: the PRO-CARBO phase II trial. Ther Adv Urol. 2024 Feb 28;16:17562872241229876. doi: 10.1177/17562872241229876. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: No
Related trials for Castration-resistant Prostate Cancer
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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
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
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin in people with Castration-resistant Prostate Cancer and Metastasis, run by Centre Francois Baclesse at 4 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 11 inclusion and 5 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of Carboplatin on Metastatic Prostatic Carcinoma Resistant to Castration Efficacy of Carboplatin: The Best Radiological Tumoral Response Rate (time frame: Up to 27 weeks (9 cycles)). The study lists 2 primary outcomes in all. 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 NCT03652493, which also lists 1 linked publication.
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 11 Jun 2026.