Trial Outcomes & Findings for Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway (NCT NCT03652493)
NCT ID: NCT03652493
Last Updated: 2026-06-11
Results Overview
Tumoral response rate (TR) defined according to the recommendations of the PCWG3 criteria : Objective radiological response
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 27 weeks (9 cycles)
Results posted on
2026-06-11
Participant Flow
One patient dropped out of the study before starting treatment due to rapid deterioration of general condition.
Participant milestones
| Measure |
CARBOPLATIN
CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CARBOPLATIN
n=15 Participants
CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles
|
|---|---|
|
Age, Continuous
|
67 years
n=15 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Up to 27 weeks (9 cycles)Tumoral response rate (TR) defined according to the recommendations of the PCWG3 criteria : Objective radiological response
Outcome measures
| Measure |
CARBOPLATIN
n=15 Participants
CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles
|
|---|---|
|
Efficacy of Carboplatin on Metastatic Prostatic Carcinoma Resistant to Castration Efficacy of Carboplatin: The Best Radiological Tumoral Response Rate
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 27 weeks (9 cycles)Biological response rate (TR) defined according to the recommendations of the PCWG3 criteria : Decrease of PSA ≥ 50%,
Outcome measures
| Measure |
CARBOPLATIN
n=15 Participants
CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles
|
|---|---|
|
Efficacy of Carboplatin: Biological Response Rate Defined by Value of PSA
|
1 Participants
|
Adverse Events
CARBOPLATIN
Serious events: 6 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CARBOPLATIN
n=15 participants at risk
CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles
|
|---|---|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FALL
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
BONE MARROW FAILURE
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
GENERAL PHYSICAL HEALTH DETERIORATION
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
Other adverse events
| Measure |
CARBOPLATIN
n=15 participants at risk
CARBOPLATIN in Intraveinous Dose AUC 5 according to Calvert every 3 weeks, for a duration of 6 to 9 cycles
|
|---|---|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHOPENIA
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
NERVOUS SYSTEM DISORDERS
SYNCOPE
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
INVESTIGATIONS
BLOOD ALKALINE PHOSPHATASE INCREASED
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
VASCULAR DISORDERS
HOT FLUSH
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
53.3%
8/15 • Number of events 8 • From study start to 1 year
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
33.3%
5/15 • Number of events 6 • From study start to 1 year
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
46.7%
7/15 • Number of events 7 • From study start to 1 year
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
13.3%
2/15 • Number of events 2 • From study start to 1 year
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
THROMBOCYTOPENIA
|
66.7%
10/15 • Number of events 11 • From study start to 1 year
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
GROIN PAIN
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
NEUTROPENIA
|
40.0%
6/15 • Number of events 6 • From study start to 1 year
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
66.7%
10/15 • Number of events 12 • From study start to 1 year
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
OEDEMA GENITAL
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOKALAEMIA
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
13.3%
2/15 • Number of events 2 • From study start to 1 year
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
CHEST PAIN
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
13.3%
2/15 • Number of events 2 • From study start to 1 year
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNOEA
|
20.0%
3/15 • Number of events 4 • From study start to 1 year
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL MOTILITY DISORDER
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
INVESTIGATIONS
WEIGHT DECREASED
|
13.3%
2/15 • Number of events 2 • From study start to 1 year
|
|
GASTROINTESTINAL DISORDERS
DRY MOUTH
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
NERVOUS SYSTEM DISORDERS
TREMOR
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
EYE DISORDERS
VISION BLURRED
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
HEPATOBILIARY DISORDERS
CHOLESTASIS
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
RENAL AND URINARY DISORDERS
CHRONIC KIDNEY DISEASE
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BONE PAIN
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PAIN
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
6.7%
1/15 • Number of events 1 • From study start to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place