Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Prostatic Neoplasms

Disease Progression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Kennedy Disease

All Drugs and Chemicals

Dermatologic Agents

Androgens

Coal Tar

Androgen Receptor Antagonists

Participants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 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.

Participants will receive placebo to match apalutamide (4 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.

Apalutamide Oral Tablet [Erleada]

Placebo

Aneta Drozd

Vincent J Gnanapragasam, Prof.

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.

The trial will occur in two stages. Following an initial 3-arm Pilot stage, a go-no go decision will be made. If successful, the trial will progress and adapt to become a 2-arm trial in the subsequent stage.

TherApeutics in Early ProState Cancer (TAPS02)

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).

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.

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.

Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC-QLQC30).

Spots Global Cancer Trial Database for apalutamide oral tablet [erleada]