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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Malignant neoplasms of male genital organs
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The BARCODE 2 study is a two staged open-label, single centre, and single treatment phase II study. The study will invite participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed after treatment with docetaxel chemotherapy and androgen receptor-directed therapy (e.g., enzalutamide or abiraterone) to initially investigate whether they have a mutation in a gene that will likely have contributed to the development of their cancer. Knowledge of the inherited genetic status of DNA repair genes will be used to alter the treatment pathway for mCRPC patients. It is known that a mutation (error) in certain genes can cause or contribute to the development of cancer. Some of these genes are called ‘DNA repair genes’ as they help correct errors when DNA replicates itself. Errors in these genes then also lead to a higher risk of developing certain types of cancer, including breast, ovarian and prostate cancer. There is evidence that carriers of these mutations with other types of cancer, such as breast and ovarian cancer are more responsive to chemotherapy treatments that contain platinum, and emerging evidence suggests that this may also be the case for men with prostate cancer.
Participants will be identified for enrolment to the study by either being a known carrier of a mutation in a DNA repair gene having had a clinical genetic test prior to enrolment or by undergoing genetic testing (screening) within the study. The participants consent will be sought for this initial (genetic mutation confirmation) stage. Those with a mutation found will be asked to consent to the treatment stage of the study and offered carboplatin chemotherapy and will be assessed with imaging and prostate specific antigen (PSA) levels for response to treatment.
Participants will be followed until death to measure survival outcomes. This is a hypothesis generating study, to test the platinum sensitivity of prostate tumours that have developed due to a mutation in a DNA repair gene. This study will provide data to use in a larger clinical trial of platinum chemotherapy based on patients’ germline genetic signature and/or tumour genetic profile.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Drug;
You can take part if:
You may not be able to take part if:
Exclusion Criteria (for part 1 and 2) 1. Critical organ metastases (e.g. spinal metastases with risk of cord compression) as documented on most recent imaging report. 2. Patients with bleeding tumours. 3. Previous treatment with a platinum chemotherapy drug for prostate cancer. 4. Previous treatment with a PARP inhibitor 5. Patients with a history of severe allergic to carboplatin or other platinum-containing compounds 6. Patients unfit for chemotherapy or those with ongoing neuropathy >grade 1 (sensory or motor) according to NCI CTCAE V4.02. 7. Known and documented hearing impairment 8. Other active malignancies or previous malignancies likely, in the PI’s opinion, to impact on management of mCRPC. 9. Significant documented cardiovascular disease: severe/unstable angina, myocardial infarction less than 6 months prior to trial entry, arterial thrombotic events less than 6 months prior to trial entry, clinically significant cardiac failure requiring treatment (NYHA II-IV). 10. Cerebrovascular disease (CVA or TIA) in the preceding 2 years to entry to Part 2 of study. 11. Presence of symptomatic brain metastases.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Institute of Cancer Research: Royal Cancer Hospital and funded by European Commission .
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for Trial ID: CPMS 32051
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