Professor John Kelly Clinical Trials for bladder prostate penile cancer

We use clinical trials to research new diagnosis and treatment approaches for bladder cancer and prostate cancer and to see if they are more effective than the standard approaches already available. This may be testing a new drug, testing a novel surgical technique or giving an existing drug in a different way. We aim to find the approaches that work best and cause the fewest side effects.


New treatment approaches have to go through three main phases of clinical trial to ensure that they are safe and effective. Phase 1 (usually written as “Phase I”) trials are usually small trials, recruiting only a few patients to examine doses and side effects. This early stage work must be completed before we can move on to testing the new treatment to see if it actually works.


By the time a clinical trial has reached Phase III we are aiming to see whether the new treatment is more effective than the best currently available treatment. The difference in success of the new treatment may be very small, so these trials usually involve a lot of patients to ensure that the differences are consistent. Our work frequently involves Phase III trials which we are confident can improve the care we provide.


Our studies look at the effectiveness of new diagnosis and treatment approaches as well as the side effects and impact on your quality of life.

iROC is a randomised trial comparing the efficacy of a totally minimally invasive robotic cystectomy (intracorporeal) versus traditional open cystectomy in patients with bladder cancer. This is in response to NHS England statement that there is insufficient evidence to support routine commissioning of robotic cystectomy.

We are investigating whether a new urine test called UroMark can detect bladder cancer in patients who are being investigated for haematuria (blood in the urine).

UroMark is currently in the development stage and early results indicate that it can detect bladder cancer with a high degree of certainty. The test detects changes in the DNA of cells which are present in urine. Changes in DNA, called mutations or epigenetic alterations, are present in cells collected from a urine sample if cancer is present. We would like to understand if the UroMark test can detect bladder cancer.

DETECT II will validate the accuracy of the Uromark test in patients with all types of bladder cancer (stage and grade) and in especially low grade  bladder cancer. Our aim is to show that the test has enough accuracy to detect all bladder cancers. 

We think that incorporating this very sensitive and specific test will change the way that bladder cancer is diagnosed in hospitals everywhere.

The HYMN trial was a Phase III trial evaluating hyperthermic mitomycin in patients with a recurrence of bladder cancer after BCG therapy. The trial recruited patients across 10 UK sites and is now completed. We hope to publish the results of HYMN in the very near future and will post an update here.

HIVEC-II (bladder cancer)

This trial is looking at mitomycin C (a chemotherapy drug) alongside a new treatment called hyperthermia for people with early stage bladder cancer. It is for people with newly diagnosed bladder cancer or bladder cancer that has come back after initial treatment.

CALIBER is a phase II trial looking at different ways of treating early stage bladder cancer that has come back after treatment. It is comparing surgery with a type of chemotherapy called mitomycin C. It is for people with the most common type of bladder cancer called transitional cell cancer.

This trial is comparing a white light with a blue light during surgery for people who have been recently diagnosed with early bladder cancer.

In this trial we want to test using a blue light during surgery alongside a liquid that is put into the bladder. The liquid is absorbed by the cancer cells and glows red under the blue light. This may help us to see the areas of cancer more clearly and remove it.

The BOXIT trial compared standard treatment and celecoxib (an anti-inflammatory drug) with standard treatment alone for bladder cancer. Celecoxib is a type of drug called a COX-2 inhibitor. COX-2 inhibitors block the action of a protein that may help cancer cells to grow.

This study compared traditional open cystectomy surgery (removal of the bladder) with keyhole surgery, or robotic surgery, for bladder cancer.

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