Current Research
About the Project
The purpose of this study is to see if Apalutamide either used alone or combined in tablet with abiraterone acetate and prednisone, plus androgen deprivation therapy (also known as hormone therapy/ADT), is safe and could improve the results of surgery and delay the time it takes for prostate cancer to spread to other parts of the body in patients with localised and locally advanced high-risk prostate cancer who are planned for radical prostatectomy (RP). All participants in this study will get Androgen Deprivation Therapy (ADT) prior and after the RP surgery. This treatment is not considered standard of care which means that it is a therapy that you normally would not receive outside of a clinical trial and it has not been proven to benefit patients. In this study, ADT is a gonadotropin releasing hormone (GnRH) agonists. GnRH agonists are drugs that lower the production of androgens (male hormones) in your body. Prostate cancer cells usually require androgens, such as testosterone, to grow. You will be randomised into one of two treatment groups, both receiving ADT but only one receiving the study drug apalutamide.
MoonRISe-1 is a clinical research study of an investigational drug delivery system for adults with intermediate-risk non-muscle invasive bladder cancer.
The MoonRISe-1 study is evaluating an investigational drug delivery system called TAR-210.
Study doctors want to learn more about the effects of TAR-210 when it delivers controlled doses of an investigational medication (erdafitinib) into the bladder over approximately 12 weeks.
The TAR-210 is a small, flexible tube that is inserted into the bladder by a healthcare professional using a urinary catheter.
TAR-210 is not approved for use by any regulatory authority and can only be used in research studies such as this one.
Suitability for this trial includes testing your bladder tumour for specific genetic alterations called fibroblast growth factor receptor (FGFR) alterations.
FGFR alterations can be a factor in tumour growth and whether the cancer spreads.
FGFR testing needs to be performed on a urine and/or tumour tissue sample collected at screening.
If your tumour has the required FGFR alterations, you may be eligible to participate in the MoonRISe-1 study.
If you are eligible for this study, you will be randomly assigned to either :
Group A: The investigational drug delivery system (TAR-210)
OR Standard of Care Chemotherapy (intravesical Mitomycin C)
CLIMATE: A comparison of diagnostic accuracy of Luminal Index and Standard of Care MRI for Accelerated detection of significant prostate cancer
This study is trying to establish if a scanning method called Luminal Index MRI (LI-MRI) might be able to be as good as the Standard of Care MRI (SOC-MRI).
A LI-MRI scan takes only 5-10 minutes compared to up to 45 minutes needed for a SOC-MRI scan and it does not require the injection of dye to improve images.
Most people that enter the study will have had a PSA (Prostate Specific Antigen) blood test with a higher-than-normal reading.
Routinely, the next step would be to have a SOC-MRI scan of the prostate to investigate.
Participants to the trial will have both types of MRI, the usual SOC-MRI plus the new LI-MRI in the same scan session.
The purpose of the MRI is to produce an image that your doctor examines to look for anything of concern that needs to be investigated further.
If there is, the doctor would usually take samples of prostate tissue (biopsies) using a needle that would then be examined under a microscope to see if what was seen on the MRI image was cancer or caused by something else.
TAPS 02: Early stage prostate cancer can be managed by active surveillance, where patients are closely monitored. If the cancer reaches a certain stage (“progresses”) the patient can access curative treatment (such as surgery or radiotherapy). In the TAPS02 trial we are testing to see if we can slow down this chance of progression or maybe even stop it using short-term drug treatment.
The drug used is Apalutamide. It belongs to a group of drugs that work by blocking androgens (male hormones). By blocking the effect of androgens, apalutamide stops prostate cancer cells from growing and dividing. Doctors currently use apalutamide to treat men with non-metastatic castration-resistant prostate cancer (prostate cancer for which initial treatments have failed).
In the TAPS02 trial we are testing if short-term apalutamide might slow tumour growth and make it less likely for men on surveillance to progress and need treatment. Eligible participants are randomly selected to receive apalutamide or placebo and followed up accordingly with blood tests, health checks and imaging.
Trials in follow up
POUT: Comparing peri-operative chemotherapy and surveillance in upper tract urothelial cancer.
RADICALS: Evaluating radiotherapy and androgen deprivation in combination after local surgery.
SORCE: Comparing Sorafenib with placebo in patients with resected primary renal cell carcinoma at high or intermediate risk of relapse.
PURE: Evaluating clinical effectiveness of surgical interventions or stones in the lower pole of the kidney: percutaneous nephrolithotomy, flexible ureterorenoscopy and lithotripsy.
ADD-ASPIRIN: assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic cancers.
UKGCPS: Identifying genes which suggest a predisposition to prostate cancer developing.
To see more details about our current research opportunities, please visit: Urology Current Research | North Bristol NHS Trust
