- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05191680
TherApeutics in Early ProState Cancer (TAPS02)
January 25, 2024 updated by: Vincent Gnanapragasam, Cambridge University Hospitals NHS Foundation Trust
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 3, 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
402
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aneta Drozd
- Phone Number: 01223256364
- Email: cuh.taps02trial@nhs.net
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Recruiting
- Addenbrooke's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
INCLUSION CRITERIA
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.
- 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
EXCLUSION CRITERIA
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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Apalutamide 6 months
Participants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 months.
|
Apalutamide is a selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.
Other Names:
|
Experimental: Apalutamide 3 months + Placebo 3 months
Participants 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.
|
Apalutamide is a selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.
Other Names:
|
Placebo Comparator: Placebo 6 months
Participants will receive placebo to match apalutamide (4 tablets) orally once a day for up to 6 months.
|
Placebo to match apalutamide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI defined tumour volume (Pilot)
Time Frame: 12 months after end of treatment
|
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.
|
12 months after end of treatment
|
Cumulative rate of disease progression (Full Trial)
Time Frame: 3 years after completion of treatment
|
To determine whether there is a 50% reduction in cumulative 3-year progression rate to ≥ Grade Group 3 or T3 stage and composite score of ≥ CPG3 disease.
|
3 years after completion of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reported adverse events (Pilot)
Time Frame: Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)
|
As per NCI-CTCAE v5.0
|
Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)
|
Reported adverse events (Full Trial)
Time Frame: Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)
|
As per NCI-CTCAE v5.0
|
Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)
|
Patient-reported outcomes (Pilot) EORTC-QLQC30
Time Frame: Cumulative until 12 months after end of treatment
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Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC-QLQC30).
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Cumulative until 12 months after end of treatment
|
Patient-reported outcomes (Pilot) EQ-5D-5L
Time Frame: Cumulative until 12 months after end of treatment
|
Assessed using the EQ-5D-5L questionnaire developed by the EuroQol Group.
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Cumulative until 12 months after end of treatment
|
Patient-reported outcomes (Full Trial) EORTC-QLQC30
Time Frame: Cumulative until 3 years after completion of treatment
|
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC-QLQC30).
|
Cumulative until 3 years after completion of treatment
|
Patient-reported outcomes (Full Trial) EQ-5D-5L
Time Frame: Cumulative until 3 years after completion of treatment
|
Assessed using the EQ-5D-5L questionnaire developed by the EuroQol Group.
|
Cumulative until 3 years after completion of treatment
|
Cumulative rate of progression (any progression) (Full Trial)
Time Frame: 3 years after completion of treatment
|
the overall rate of disease progression
|
3 years after completion of treatment
|
Cumulative rate of progression to any prostate cancer treatment (for any cause) (Full Trial)
Time Frame: 3 years after completion of treatment
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the overall rate of conversion to treatment for any causes
|
3 years after completion of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vincent J Gnanapragasam, Prof., Cambridge University Hospitals NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2023
Primary Completion (Estimated)
April 1, 2031
Study Completion (Estimated)
April 1, 2031
Study Registration Dates
First Submitted
December 16, 2021
First Submitted That Met QC Criteria
January 11, 2022
First Posted (Actual)
January 13, 2022
Study Record Updates
Last Update Posted (Actual)
January 26, 2024
Last Update Submitted That Met QC Criteria
January 25, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAPS02
- 2021-006106-75 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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