TherApeutics in Early ProState Cancer (TAPS02)

Phase 3

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Apalutamide Oral Tablet [Erleada]; Drug: Placebo

• Registration Number: NCT05191680
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-13
• Study Start: 2023-04-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04
• Primary Completion: 2031-04
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 402

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apalutamide 6 months	Apalutamide Oral Tablet [Erleada]	Participants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 months.
Apalutamide 3 months + Placebo 3 months	Apalutamide Oral Tablet [Erleada]	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.
Placebo 6 months	Placebo	Participants will receive placebo to match apalutamide (4 tablets) orally once a day for up to 6 months.

Primary Outcome Measures

Name	Time	Method
Cumulative rate of disease progression (Full Trial)	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.
MRI defined tumour volume (Pilot)	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.

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcomes (Full Trial) EQ-5D-5L	Cumulative until 3 years after completion of treatment	Assessed using the EQ-5D-5L questionnaire developed by the EuroQol Group.
Cumulative rate of progression (any progression) (Full Trial)	3 years after completion of treatment	the overall rate of disease progression
Reported adverse events (Pilot)	Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)	As per NCI-CTCAE v5.0
Patient-reported outcomes (Pilot) EORTC-QLQC30	Cumulative until 12 months after end of treatment	Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC-QLQC30).
Patient-reported outcomes (Pilot) EQ-5D-5L	Cumulative until 12 months after end of treatment	Assessed using the EQ-5D-5L questionnaire developed by the EuroQol Group.
Reported adverse events (Full Trial)	Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)	As per NCI-CTCAE v5.0
Patient-reported outcomes (Full Trial) EORTC-QLQC30	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 rate of progression to any prostate cancer treatment (for any cause) (Full Trial)	3 years after completion of treatment	the overall rate of conversion to treatment for any causes

Trial Locations

Locations (4)

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Darent Valley Hospital; 🇬🇧 Dartford, United Kingdom

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom