The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment (BARCODE2)
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ClinicalTrials.gov Identifier: NCT02955082 |
Recruitment Status :
Recruiting
First Posted : November 4, 2016
Last Update Posted : June 8, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hormone Refractory Prostate Cancer | Drug: Carboplatin | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 450 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment |
Actual Study Start Date : | May 25, 2017 |
Estimated Primary Completion Date : | September 30, 2024 |
Estimated Study Completion Date : | September 30, 2024 |

Arm | Intervention/treatment |
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Experimental: Carboplatin
Patients with a germline DNA repair gene mutation identified in part 1 of the study, or who are already known to have a germline mutation will undergo assessment for inclusion in part 2 of the study to receive Carboplatin treatment.
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Drug: Carboplatin
Intravenous carboplatin infusion every 3 weeks.
Other Name: Paraplatin |
- Radiographic Treatment Response [ Time Frame: 6 weeks ]Response rate to two cycles of platinum chemotherapy in patients with mCRPC and germline DNA repair gene mutations using the modified response evaluation criteria in solid tumours (RECIST) 1.1 criteria. In participants with bone only metastatic disease, response will be recorded as having 'new lesions' or 'no new lesions' (as per the Prostate Cancer Working Group 3 (PCWG3) guidance). Participants with no new bone lesions will be deemed as having stable disease. These participants can respond by PSA as defined below.
- Radiographic Treatment Response [ Time Frame: 9 weeks ]Response rate to three cycles of platinum chemotherapy in patients with mCRPC and germline DNA repair gene mutations via bone scan assessment. In participants with bone only metastatic disease, response will be recorded as having 'new lesions' or 'no new lesions' (as per PCWG3 guidance). Participants with no new bone lesions will be deemed as having stable disease. These participants can respond by PSA as defined below.
- Biochemical Treatment Response [ Time Frame: 6 weeks ]Reduction of more than 50% in PSA levels in response to two cycles of platinum chemotherapy in patients with mCRPC and germline DNA repair gene mutations.
- Overall survival of men with mCRPC and germline DNA repair gene mutations [ Time Frame: This will be evaluated 3 months after end of study treatment ]Overall survival of patients with mCRPC and a DNA repair gene mutation treated with carboplatin.
- Progression-free survival of men with mCRPC and germline DNA repair gene mutations [ Time Frame: This will be evaluated 3 months after end of study treatment ]Progression free survival of patients with mCRPC and a DNA repair gene mutation treated with carboplatin.
- Incidence of germline DNA repair gene mutations in a population of mCRPC cases [ Time Frame: Through study completion, up to 3 years ]Incidence of germline DNA repair gene mutations will be calculated from the rate of pathogenic mutations observed in the group of men who undergo genetic profiling within part 1 of the study.
- Bone scan response [ Time Frame: Through study completion, up to 3 years ]Bone scan response (new lesion vs. no new lesions) at each time point in patients with bone-only metastatic disease.
- Cause specific survival [ Time Frame: This will be evaluated 3 months after end of study treatment ]Cause specific survival from date of first diagnosis of prostate cancer in patients with DNA repair gene mutations.
- Radiographic progression free survival [ Time Frame: This will be evaluated 3 months after end of study treatment ]Radiographic Progression free survival will be measured from the date of trial entry to the first occurrence of radiographic progression or death.
- Time to radiographic progression [ Time Frame: This will be evaluated 3 months after end of study treatment ]Time to radiographic progression will be measured from the date of trial entry to the first occurrence of radiographic progression.
- PSA objective responses [ Time Frame: This will be evaluated 3 months after end of study treatment ]PSA response and PSA progression are defined according to the consensus guidelines of the Prostate Cancer Working Group 3 (PCWG3).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Eligible participants must be male at birth. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All study participants will be assessed according to the part 1 and/ or part 2 inclusion criteria depending on which part of the study they enter initially.
For Part 1 (genetic screening) of the study:
- Age ≥ 18 years.
- Recorded diagnosis of prostate cancer with or without histological confirmation. Patients who have not previously undergone a prostate (or metastatic) biopsy but are confirmed to have a raised PSA (>80ng/ml at any time), metastatic disease on imaging and have undergone treatment for mCRPC are eligible.
- Castration-resistant disease defined as biochemical or radiological progression on/after treatment with orchidectomy or LHRH analogues as per PCWG3 criteria.
- Confirmed metastatic disease on conventional imaging methods such as CT, bone scan or PET imaging.
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Current or previous treatment includes at least one of the following:
- Docetaxel (either in hormone sensitive or resistant setting; Patients who have completed treatment with or are currently undergoing Cabazitaxel chemotherapy are also eligible)
- Enzalutamide
- Abiraterone
- Adequate renal function measured by calculated GFR (Cockcroft-Gault) >30ml/min. If a participant had renal dysfunction that is expected to improve, they may be considered for part 1 of the study.
- Adequate haematological function to allow study entry in line with local hospital practice or at the investigator's discretion.
- WHO performance status 0-2 as assessed and documented by study doctor.
- Life expectancy >12 weeks
- Participants with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present
- The subject is capable of understanding and complying with the protocol requirements and has signed the BARCODE 2 informed consent form.
In addition to the above, for Part 2 of the study:
- Confirmed pathogenic germline mutation in a DNA repair gene. (Participants with a known germline mutation will need to provide a report from the external laboratory where genetic testing was carried out)
- Previous treatment with docetaxel and abiraterone or enzalutamide with documented disease progression prior to entry to part 2 (rising PSA and/or radiographic progression). Patients previously treated with cabazitaxel and who have documented disease progression are also eligible.
- Adequate haematological function: Haemoglobin (Hb) ≥8.0g/dL, neutrophil count ≥1.5x109/L and platelets ≥100x109/L.
- Adequate liver function: Total bilirubin ≤1.5 x upper limit of normal (ULN) except for participants with known Gilbert's syndrome; AST and ALT ≤ 2.5x ULN in the presence of liver metastases.
- Adequate renal function: creatinine clearance >30ml/min measured by a glomerular filtration rate (GFR) clearance test. If a measured GFR test is not available, then calculated GFR is acceptable (measured GFR must be carried out by cycle 2 of carboplatin).
Exclusion Criteria (for part 1 and 2):
- Critical organ metastases (e.g. spinal metastases with risk of cord compression) as documented on most recent imaging report.
- Participants with bleeding tumours.
- Previous treatment with a platinum chemotherapy drug for prostate cancer.
- Previous treatment with a PARP inhibitor
- Participants with a history of severe allergic reaction to carboplatin or other platinum-containing compounds
- Exposure to yellow fever vaccine in the previous 6 months.
- Participants unfit for chemotherapy or those with ongoing neuropathy >grade 1 (sensory or motor) according to NCI CTCAE V4.02.
- Known and documented hearing impairment
- Other active malignancies or previous malignancies likely, in the PI's opinion, to impact on management of mCRPC.
- 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).
- Cerebrovascular disease (CVA or TIA) in the preceding 2 years to entry to Part 2 of study.
- Presence of symptomatic brain metastases.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955082
Contact: Elizabeth K Bancroft, PhD | +44 207 808 2136 | elizabeth.bancroft@icr.ac.uk | |
Contact: Eva McGrowder, PhD | +44 20 8722 4483 | eva.mcgrowder@icr.ac.uk |
United Kingdom | |
Institute of Cancer Research and Royal Marsden Hospital | Recruiting |
Sutton, Surrey, United Kingdom, SM2 5PT | |
Contact: Rosalind A Eeles, FRCP FRFR 02086613642 rosalind.eeles@icr.ac.uk | |
Principal Investigator: Rosalind A Eeles, FRCP FRCR |
Principal Investigator: | Rosalind A Eeles, FRCP, FRFR | Institute of Cancer Research and Royal Marsden Hospital |
Responsible Party: | Institute of Cancer Research, United Kingdom |
ClinicalTrials.gov Identifier: | NCT02955082 |
Other Study ID Numbers: |
CCR4520 |
First Posted: | November 4, 2016 Key Record Dates |
Last Update Posted: | June 8, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymised data can be applied for via the Data Access Committee. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Prostatic Diseases Carboplatin Antineoplastic Agents |