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Prostate CancerPhase 2NCT05191680

TherApeutics in Early ProState Cancer (TAPS02)

A Phase 2 study testing Apalutamide Oral Tablet [Erleada] in people with Prostate Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 6 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Apalutamide Oral Tablet [Erleada]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
6 sitesUnited Kingdom
Study dates
24 Apr 2023to Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be included in the trial the patient must:
  • Have given written informed consent to participate.
  • Be aged 18 or over.
  • Have an Eastern Cooperative Oncology Group (ECOG) status 0-2.
  • Have selected active surveillance as a management option.
  • Have an MRI detectable lesion with an M score of ≥ 3 using Likert scale OR PI-RADS (version 2.1) reporting criteria. If M score is 3 then lesion size (single or combined) of ≥10mm.
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  • Have prostate cancer from a combination of image guided targeted + systematic biopsies and MRI lesion and biopsy are concordant for a prostate cancer diagnosis.
  • Not anticipated to require bladder outlet surgery during IMP treatment or for up to 12 months of follow-up.
  • Meet all of the following clinical laboratory assessment criteria:
  • Haemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomisation.
  • Platelet count ≥ 100 x 109/L independent of transfusion and/or growth factors within 3 months prior to randomisation.
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L within 21 days prior to randomisation.
  • Serum albumin ≥ 3.0 g/dL within 21 days prior to randomisation.
  • Glomerular filtration rate (GFR) ≥ 30 ml/min AND Serum creatinine ≤ 3 times the ULN (calculated by Cockcroft and Gault equation using actual body weight) within 21 days prior to randomisation.
  • Serum potassium ≥3.5 mmol/L within 21 days prior to randomisation.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × ULN AND Serum total bilirubin ≤1.5 × ULN within 21 days prior to randomisation (Note: In patients with confirmed Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, patient may be eligible in consultation with their physician).
  • Have prostate cancer with any one or more of the following:
  • CPG2 (based on Grade Group 2 on histology)
  • CPG1 (based on Grade Group 1 on histology) with PSA high density (PSAd >0.15) and LIKERT or PI-RADS 4/5 lesion (individual or combined) of ≥10mm size.
  • CPG1 with PSA high density (PSAd >0.15) and ≥50% biopsy core involvement (number of positive cores/all cores taken) with target biopsies counted as one if LIKERT or PI-RADS 3 lesion

Who cannot join

  • The presence of any of the following will preclude patient inclusion:
  • Contraindications to apalutamide or its excipients.
  • Pelvic metalwork interfering with MRI prostate interpretation.
  • Any prior or concurrent use of androgen deprivation therapy (ADT) or androgen receptor targeting agents (not including established and continued use of 5-ARIs for urinary symptoms).
  • Systemic therapy for prostate cancer.
  • Inability for patient to have prostate MRI scan.
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  • Concurrent involvement in a Clinical Trial of Investigational Medicinal Product (CTIMP); participation in an observational trial/studies is acceptable.
  • Seizure or known condition that may pre-dispose to seizure (including but not limited to the following within 1 year prior to randomisation: prior stroke, transient ischemic attack, loss of consciousness, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing oedema or mass effect).
  • Medications known to lower the seizure threshold or cause seizures must be discontinued or substituted at least 28 days prior to randomisation.
  • In the opinion of investigator, patient is at increased risk of falls or fractures.
  • Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomisation. Cardiovascular risk factors should be optimised i.e. hypertension, diabetes, dyslipidaemia.
  • Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 90 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  • Gastrointestinal disorder affecting absorption.
  • Medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g., quinidine, disopyramide) or class III (e.g., amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics (e.g. haloperidol). Alternative therapy, for the prohibited medication known to prolong the QTc, may be inistigated. A minimum washout for the discontinued medication of ≥ 4 half-lives is required prior to starting IMP.
  • Symptoms suggestive of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth Young contact

01223 256364

cuh.taps02trial@nhs.net

6 sites in 1 country

United Kingdom6 sites, 6 recruiting

  • Southmead Hospital

    Bristol, BS10 5NB

    Recruiting

  • West Suffolk Hospital

    Bury St Edmunds, IP33 2QZ

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

    Recruiting

  • Darent Valley Hospital

    Dartford, DA2 8DA

    Recruiting

  • St Bartholomew's Hospital

    London, E1 1FR

    Recruiting

  • The Royal Marsden Hospital - Chelsea

    London, SW3 6JJ

    Recruiting

Other trials in United Kingdom

About this study

Official title: Targeted Drug Intervention in Men at Risk of Progression on Active Surveillance for Early Prostate Cancer: A Randomised Trial - Therapeutics in Active Prostate Cancer Surveillance (TAPS02).

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
Prostate Cancer
Being tested
Apalutamide Oral Tablet [Erleada], Placebo
Keywords
active surveillance, prostate cancer, therapeutics in prostate cancer, apalutamide, short term androgen deprivation therapy, androgen receptor inhibitor
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apalutamide Oral Tablet [Erleada]Drug

    Also called Erleada

    Apalutamide is a selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.

  • PlaceboDrug

    Placebo to match apalutamide

Study groups in NCT05191680
Study groupRoleWhat they receive
Apalutamide 6 monthsExperimentalParticipants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 months.
Receives: Drug: Apalutamide Oral Tablet [Erleada]
Apalutamide 3 months + Placebo 3 monthsExperimentalParticipants will receive apalutamide 240mg (4 x 60 mg tablets) orally once a day for up to 3 months followed by placebo to match apalutamide (4 tablets) orally once a day for up to 3 months.
Receives: Drug: Apalutamide Oral Tablet [Erleada]; Drug: Placebo
Placebo 6 monthsPlacebo comparatorParticipants will receive placebo to match apalutamide (4 tablets) orally once a day for up to 6 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRI defined tumour volume

    To determine whether there is a reduction in MRI defined tumour volume at 12 months post treatment in at least 50% of the treated cohort in either treatment arm compared to the baseline measurement.

    Measured: 12 months after end of treatment

Secondary outcomes (5)

  1. Reported adverse events

    As per NCI-CTCAE v5.0

    Measured: Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)

  2. Patient-reported outcomes EORTC QLQ-C30

    Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30).

    Measured: Cumulative until 12 months after end of treatment

  3. Patient-reported outcomes EQ-5D-5L

    Assessed using the EQ-5D-5L questionnaire developed by the EuroQol Group.

    Measured: Cumulative until 12 months after end of treatment

  4. Cumulative rate of progression (any progression)

    the overall rate of disease progression

    Measured: 3 years after completion of treatment

  5. Cumulative rate of progression to any prostate cancer treatment (for any cause)

    the overall rate of conversion to treatment for any causes

    Measured: 3 years after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2022
  2. Study start24 Apr 2023
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05191680
Sponsor's protocol ID
TAPS02
Other IDs
2021-006106-75
Status last verified
Oct 2024
First submitted
16 Dec 2021
Last updated
20 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apalutamide Oral Tablet [Erleada] in people with Prostate Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth Young (01223 256364, cuh.taps02trial@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI defined tumour volume (time frame: 12 months after end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05191680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2025.

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