Clinical trial · Interventional
Therapeutics in Active Prostate Cancer Surveillance
Targeted Drug Intervention to Inhibit Cancer Progression in Men on Active Surveillance for Prostate Cancer. Therapeutics in Active Prostate Cancer Surveillance (TAPS01)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Testing if short-term use of apalutamide can reduce image defined tumour volumes in men with detectable lesion on multi-parametric Magnetic Resonance Imaging (mpMRI) and being managed by Active Surveillance. The trial will also evaluate the tolerability and side effect profile of men on AS using short term apalutamide and patient acceptability as a therapeutic strategy, as well as determining feasibility of a larger prospective randomised trial of apalutamide.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apalutamide | Drug | Apalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- apalutamide, 240mg (4x60mg tablets) orally, daily for a max. duration of 90 continuous days.
- interventionNames
- Drug: Apalutamide
Primary outcomes (1)
- measure
- Physiological Response
- timeFrame
- over a 90 day treatment period
- description
- Tumour volume downsizing/absence of lesion, as determined by mpMRI
Secondary outcomes (2)
- measure
- Patient Reported Outcomes
- timeFrame
- over 120 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Given Informed Consent (IC) to participate * Age 18 or over * Eastern Cooperative Oncology Group (ECOG) status 0-2 * Diagnosed with prostate cancer * Patient selection of active surveillance as a management option * mpMRI detectable lesion * Prostate cancer on biopsy from a mpMRI defined lesion * No contraindications to apalutamide * Normal full blood count and normal renal and liver function tests * At least 6 months since initiation of active surveillance and/or last rebiopsy date. * Low or intermediate risk prostate cancer according to National Institute for Health and Care Excellence (NICE) classification * M score of ≥ 3 using Prostate Imaging Reporting and Data System (PIRADS) version 2 reporting criteria Exclusion Criteria: * Contraindications to apalutamide or its excipients * Concurrent medication that can lower seizure threshold * Prior localised therapy for prostate cancer * Any prior use of androgen deprivation therapy or androgen receptor targeting agents * Any prior systemic therapy for prostate cancer * Patient unable to have prostate 3T mpMRI scan * Presence of any pelvic or hip metalwork
References
Publications (0)
Data not yet available