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| Name | Class |
|---|---|
| French Interregional Group of Clinical Research and Innovation | OTHER |
| Ligue contre le cancer, France | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARBOPLATIN | Experimental | CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Tumoral evaluation every 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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%, | Up to 27 weeks (9 cycles) |
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Inclusion Criteria:
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 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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre François Baclesse | Caen | 14076 | France | |||
| Centre Oscar Lambret |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38425504 | Derived | 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. |
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One patient dropped out of the study before starting treatment due to rapid deterioration of general condition.
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| ID | Title | Description |
|---|---|---|
| FG000 | CARBOPLATIN | CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2020 |
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| Lille |
| 59000 |
| France |
| Chu Rouen | Rouen | 76000 | France |
| Institut Gustave ROUSSy IGR | Villejuif | France |
| COMPLETED |
|
| NOT COMPLETED |
|
Among the 16 patients included, one patient dropped out of the study before starting treatment due to rapid deterioration of general condition
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| ID | Title | Description |
|---|---|---|
| BG000 | CARBOPLATIN | CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | All patients are male | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Up to 27 weeks (9 cycles) |
|
|
| |||||||||||||||||||||||||||
| Primary | 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%, | Posted | Count of Participants | Participants | Up to 27 weeks (9 cycles) |
|
|
From study start to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CARBOPLATIN | CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles | 2 | 15 | 6 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FALL | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | Systematic Assessment |
| ||
| THROMBOCYTOPENIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
| ||
| URINARY TRACT INFECTION | INFECTIONS AND INFESTATIONS | Systematic Assessment |
| ||
| VOMITING | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| NAUSEA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| BONE MARROW FAILURE | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
| ||
| GENERAL PHYSICAL HEALTH DETERIORATION | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
| ||
| PAIN | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HOT FLUSH | VASCULAR DISORDERS | Systematic Assessment |
| ||
| NAUSEA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| DECREASED APPETITE | METABOLISM AND NUTRITION DISORDERS | Systematic Assessment |
| ||
| ANAEMIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
| ||
| DIARRHOEA | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| THROMBOCYTOPENIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
| ||
| HEADACHE | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
| ||
| GROIN PAIN | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
| ||
| NEUTROPENIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
| ||
| ASTHENIA | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
| ||
| OEDEMA GENITAL | REPRODUCTIVE SYSTEM AND BREAST DISORDERS | Systematic Assessment |
| ||
| HYPOKALAEMIA | METABOLISM AND NUTRITION DISORDERS | Systematic Assessment |
| ||
| VOMITING | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| BACK PAIN | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
| ||
| CHEST PAIN | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
| ||
| ARTHRALGIA | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
| ||
| DYSPNOEA | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | Systematic Assessment |
| ||
| GASTROINTESTINAL MOTILITY DISORDER | GASTROINTESTINAL DISORDERS | Systematic Assessment |
| ||
| WEIGHT DECREASED | INVESTIGATIONS | Systematic Assessment |
| ||
| DRY MOUTH | GASTROINTESTINAL DISORDERS | Systematic Assessment |
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| CONSTIPATION | GASTROINTESTINAL DISORDERS | Systematic Assessment |
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| TREMOR | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
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| VISION BLURRED | EYE DISORDERS | Systematic Assessment |
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| CHOLESTASIS | HEPATOBILIARY DISORDERS | Systematic Assessment |
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| CHRONIC KIDNEY DISEASE | RENAL AND URINARY DISORDERS | Systematic Assessment |
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| BONE PAIN | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
| ||
| PAIN | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
| ||
| PAIN IN EXTREMITY | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | Systematic Assessment |
| ||
| ACUTE KIDNEY INJURY | RENAL AND URINARY DISORDERS | Systematic Assessment |
| ||
| FATIGUE | GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | Systematic Assessment |
| ||
| LYMPHOPENIA | BLOOD AND LYMPHATIC SYSTEM DISORDERS | Systematic Assessment |
| ||
| SYNCOPE | NERVOUS SYSTEM DISORDERS | Systematic Assessment |
| ||
| BLOOD ALKALINE PHOSPHATASE INCREASED | INVESTIGATIONS | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justine Lequesne | Centre François Baclesse | 0231455002 | j.lequesne@baclesse.unicancer.fr |
| May 15, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Male |
|
| Title | Denominators | Categories |
|---|
|