Actively Recruiting
TherApeutics in Early ProState Cancer (TAPS02)
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2025-06-20
90
Participants Needed
6
Research Sites
336 weeks
Total Duration
On this page
Sponsors
C
Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
U
University of Cambridge
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for prostate cancer.
CONDITIONS
Official Title
TherApeutics in Early ProState Cancer (TAPS02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent given
- Male aged 18 years or older
- ECOG status of 0 to 2
- Selected active surveillance as management option
- MRI detectable lesion with M score 63; 3 using Likert scale or PI-RADS 2.1 criteria
- If M score is 3, lesion size (single or combined) must be 65 10mm
- Prostate cancer diagnosis confirmed by combination of image guided targeted and systematic biopsies with MRI and biopsy concordant
- Not expected to need bladder outlet surgery during treatment and 12 months follow-up
- Meet clinical laboratory criteria: haemoglobin 63; 9.0 g/dL, platelet count 63; 100 x 10^9/L, ANC 63; 1.0 x 10^9/L, serum albumin 63; 3.0 g/dL, GFR 63; 30 ml/min, serum creatinine 64; 3 times ULN, serum potassium 63; 3.5 mmol/L, AST/ALT 64; 2.5 x ULN, total bilirubin 64; 1.5 x ULN (with special consideration for Gilbert's syndrome)
- Prostate cancer with one or more: CPG2 (Grade Group 2), CPG1 with PSA density E 0.15 and LIKERT or PI-RADS 4/5 lesion 65 10mm, or CPG1 with PSA density E 0.15 and 65 50% biopsy core involvement
You will not qualify if you...
- Contraindications to apalutamide or its excipients
- Pelvic metalwork that interferes with prostate MRI interpretation
- Prior or ongoing use of androgen deprivation therapy or androgen receptor targeting agents (except ongoing 5-ARIs for urinary symptoms)
- Systemic therapy for prostate cancer
- Unable to have prostate MRI scan
- Concurrent participation in another Clinical Trial of Investigational Medicinal Product (CTIMP)
- History of seizure or conditions predisposing to seizure within 1 year prior to randomisation
- Use of medications that lower seizure threshold unless discontinued or substituted 28 days before randomisation
- Increased risk of falls or fractures as judged by investigator
- Severe or unstable cardiovascular conditions within 6 months prior to randomisation
- Uncontrolled hypertension with systolic 63; 160 mmHg or diastolic 63; 90 mmHg
- Gastrointestinal disorders affecting absorption
- Use of medications known to prolong QT interval or cause Torsade de pointes without adequate washout
- Symptoms suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
2
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
3
West Suffolk Hospital
Bury St Edmunds, United Kingdom, IP33 2QZ
Actively Recruiting
4
Darent Valley Hospital
Dartford, United Kingdom, DA2 8DA
Actively Recruiting
5
St Bartholomew's Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
6
The Royal Marsden Hospital - Chelsea
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
E
Elizabeth Young
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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