Investigator Led Studies
Studies Open to Recruitment
ACE Study
A Phase IV study to evaluate cognitive function in
metastatic castrate resistant prostate cancer (mCRPC) patients
treated with Abiraterone Acetate + Prednisolone (AAP) or
Enzalutamide (ENZ).
Rationale: AAP and ENZ have been shown to extend patient
survival and improve health-related quality of life (QoL) for the
treatment of mCRPC. This observational study has been designed to
expand the understanding of the early impact of these cancer
treatments on the aspects of cognitive impairment, fatigue and
depression in the real world. Patients will complete a series of
cognitive assessments and QoL questionnaires at pre-defined
timepoints. This study will lead to a better patient treatment
experience and enable supportive care planning in this patient
group.
Main Inclusion/Exclusion Criteria: Males aged 18 years and over
with a diagnosis of mCRPC can be considered for the study. The
patient must be able and willing to provide informed consent and
complete trial questionnaires and cognitive assessments. Patients
will be unable to take part in the study if they are being treated
with either AAP or ENZ as part of another clinical trial or study
or if they are clinically diagnosed with dementia.
Recruiting sites: Barnet, Blackburn, Bristol, Chelmsford, Crewe,
Derby, Exeter, Lancashire, Morecambe Bay, Salford, Taunton.
Recruitment Target: 290.
Recruitment End Date: 30 September 2022.
Contact: ACE@uhbw.nhs.uk.
EPIC Trial
A Phase II Trial of Cemiplimab alone or in combination with
Standard of Care Chemotherapy in Locally Advanced or Metastatic
Penile Carcinoma
Objective: To evaluate the benefit and safety of cemiplimab, a
fully human anti-PD-1 monoclonal antibody, in combination with
standard of care chemotherapy, or, alone, where chemotherapy is not
deemed suitable in patients with inoperable (locally advanced or
metastatic) cancer of the penis.
Design: Non-randomised, open label, two arm phase II
multi-centre trial.
Main Inclusion Criteria: Patients with inoperable (locally
advanced or metastatic) histologically proven squamous cell
carcinoma of the penis or penile urethra who have had no previous
chemotherapy for treatment of penile cancer. Patients will have an
ECOG performance status of 0, 1 or 2, adequate renal, liver and
bone marrow function and measurable disease as per RECIST 1.1.
Main Exclusion Criteria: Pure verrucous carcinoma of the penis.
T1N1M0 or T2N1M0 disease. Previous chemotherapy for penile cancer.
Contraindication to any of the drugs in the proposed chemotherapy
regimen and/or to cemiplimab
Recruiting sites: Bristol, Southend - Essex, Glasgow, Leicester,
The Christie - Manchester, Norwich, St Georges - London, Truro,
UCLH - London.
Recruitment Target: 47.
Recruitment End Date: 31 March 2023.
Full Study Summary available on the Cancer Research UK page.
Contact: EPIC@uhbw.nhs.uk.
RECORD RWD evaluation
A real world data prospective evaluation of clinical outcomes in
non- metastatic castrate resistant prostate cancer (nmCRPC)
patients treated with Darolutamide in routine clinical
practice.
Objective: To describe disease characteristics of patients with
nmCRPC treated with Darolutamide in clinical practice and increase
the understanding of treatment response and management in this
patient group. It will also inform on the use of next generation
imaging in this setting.
Anonymised data will be collected for all nmCRPC patients at the
recruiting sites who start treatment with Darolutamide from
November 2020 until December 2023 and fulfil the eligibility
criteria. The decision to commence a patient on Darolutamide will
have been taken independently, prior to enrolling the patient into
the study and the patient's treatment will not be affected by
inclusion in the study. All data used in this study would be
recorded routinely by the treating hospital whether the patient is
in the study or not.
Contact: RECORD@uhbw.nhs.uk.
Studies in Follow-Up
Bristol Bladder Trial
A Phase II Trial of Combination Cabazitaxel and Cisplatin
Chemotherapy in the Neoadjuvant Treatment of Transitional Cell
Carcinoma of the Urinary Bladder.
Contact: BRISTOLBLADDER@uhbw.nhs.uk.
CONCEPT Trial
A randomised phase II pilot study of 3 weekly Cabazitaxel versus
weekly Paclitaxel chemotherapy in the first line treatment of HER2
negative metastatic breast cancer.
Contact: CONCEPT@uhbw.nhs.uk.
Publications
Concept
TBC
Bristol Bladder
Challapalli A, Masson S, White P, Dailami N, Pearson S, Rowe E,
Koupparis A, Oxley J, Abdelaziz A, Ash-Miles J, Bravo A, Foulstone
E, Perks C, Holly J, Persad R, Bahl A. A Single-arm Phase II Trial
of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for
Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder.
Clin Genitourin Cancer. 2021 Aug;19(4):325-332. doi:
10.1016/j.clgc.2021.02.001. Epub 2021 Feb 18. PMID: 33727028.
Primal
Anderson E, Rees B, Hull J, Heywood J, Preston A, Protheroe R,
Foulstone E, Greenwood R, Salisbury V, Mehta P. Intracellular
cytarabine triphosphate in circulating blasts post-treatment
predicts remission status in patients with acute myeloid leukemia.
Exp Hematol. 2019 Jun;74:13-18.e3. doi:
10.1016/j.exphem.2019.04.005. Epub 2019 May 2. PMID: 31054867.
JAVA-P
Challapalli A, Pearson S, Mitra AV, Coe M, Thomson A, Elliott T,
Kirkbride P, Pickering L, Kirk H, Foulstone E, Evans H, Bravo A,
Bahl AK. A phase II trial of cabazitaxel as second line
chemotherapy in relapsed locally advanced and/or metastatic
carcinoma of the penis. J Int Med Res. 2019 Oct;47(10):4664-4672.
doi: 10.1177/0300060519863546. Epub 2019 Sep 10. PMID: 31502503;
PMCID: PMC6833416.
Penile TPF
Nicholson S, Hall E, Harland SJ, Chester JD, Pickering L, Barber
J, Elliott T, Thomson A, Burnett S, Cruickshank C, Carrington B,
Waters R, Bahl A. Phase II trial of docetaxel, cisplatin and 5FU
chemotherapy in locally advanced and metastatic penis cancer
(CRUK/09/001). Br J Cancer. 2013 Nov 12;109(10):2554-9. doi:
10.1038/bjc.2013.620. Epub 2013 Oct 29. PMID: 24169355; PMCID:
PMC3833214.
Poster Presentations
ASCO 2022- EPIC- Trials in progress Poster
ASCO 2020- Bristol Bladder - QoL Outcome Poster
ASCO 2021- Concept- Primary Outcome Poster and Oral
Presentation
ASCO GU 2018- Bristol Bladder- Primary Outcome Poster
ASCO 2017- Concept- Trials in progress Poster
Working in Collaboration With:
