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New treatment option for Prostate Cancer
Official title TherApeutics in Early ProState Cancer (TAPS02)
ClinicalTrials.gov ID: NCT05191680
What this study is testing
What is Apalutamide Oral Tablet [Erleada]?
Apalutamide Oral Tablet [Erleada] is an investigational medicine, being studied as a potential treatment for prostate cancer.
Also referred to as Erleada.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- 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...
- Systemic therapy for prostate cancer.
- Inability for patient to have prostate MRI scan.
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- Symptoms suggestive of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Cambridgeshire, United Kingdom
- Bristol, United Kingdom
- Bury St Edmunds, United Kingdom
- Dartford, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Cambridgeshire, United Kingdom; Bristol, United Kingdom; Bury St Edmunds, United Kingdom; Dartford, United Kingdom; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.