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Gene test could match prostate cancer patients to better chemo

NCT ID NCT02955082

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether men with a certain type of advanced prostate cancer (castration-resistant) who have inherited DNA repair gene mutations respond better to the chemotherapy drug carboplatin. Researchers will first screen participants for these genetic changes, then treat those with mutations using carboplatin. The goal is to see if the tumors shrink or PSA levels drop, which could pave the way for more personalized cancer care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carboplatin (chemotherapy drug)
What this could lead to
If successful, this could show that genetic testing helps identify which men with advanced prostate cancer will benefit from carboplatin, leading to more personalized treatment.
What could go wrong
This is a small, early-phase study (Phase 2) with only 305 participants. The results may not apply to all patients, and carboplatin can cause side effects like low blood counts and fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

305 people

The number who actually took part.

Started

May 2017

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. Age ≥ 18 years. 2. 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. 3. Castration-resistant disease defined as biochemical or radiological progression on/after treatment with orchidectomy or LHRH analogues as per PCWG3 criteria. 4. Confirmed metastatic disease on conventional imaging methods such as CT, bone scan or PET imaging. 5. Current or previous treatment includes at least one of the following: 1. Docetaxel (either in hormone sensitive or resistant setting; Patients who have completed treatment with or are currently undergoing Cabazitaxel chemotherapy are also eligible) 2. Androgen receptor-directed therapy (e.g., Enzalutamide, Abiraterone) 6. 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. 7. Adequate haematological function to allow study entry in line with local hospital practice or at the investigator's discretion. 8. WHO performance status 0-2 as assessed and documented by study doctor. 9. Life expectancy \>12 weeks 10. Participants with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present 11. 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: 1. 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) 2. Previous treatment with docetaxel and androgen receptor-directed therapy (e.g., 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. 3. Adequate haematological function: Haemoglobin (Hb) ≥8.0g/dL, neutrophil count ≥1.5x109/L and platelets ≥100x109/L. 4. 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. 5. 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): 1. Critical organ metastases (e.g. spinal metastases with risk of cord compression) as documented on most recent imaging report. 2. Participants with bleeding tumours. 3. Previous treatment with a platinum chemotherapy drug for prostate cancer. 4. Previous treatment with a PARP inhibitor 5. Participants with a history of severe allergic reaction to carboplatin or other platinum-containing compounds 6. Exposure to yellow fever vaccine in the previous 6 months. 7. Participants unfit for chemotherapy or those with ongoing neuropathy \>grade 1 (sensory or motor) according to NCI CTCAE V4.02. 8. Known and documented hearing impairment 9. Other active malignancies or previous malignancies likely, in the PI's opinion, to impact on management of mCRPC. 10. 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). 11. Cerebrovascular disease (CVA or TIA) in the preceding 2 years to entry to Part 2 of study. 12. Presence of symptomatic brain metastases.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institute of Cancer Research and Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT, United Kingdom

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