Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer

Conditions

• Low Risk Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apalutamide — DRUG
  Patients will take orally everyday 240 mg of Apalutamide.

Study Details

Many prostate cancer are slow or non progressive forms that would never impair quality or quantity of like of life if undetected. For this localized prostate cancer, the recommendation is an active surveillance, however often experienced by the patient as a lack of care. Thus the introduction of new potent androgen receptor inhibitor raise the question of the benefit of early hormonal therapy in localized prostate cancers. The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor could influence the progression of localized prostate cancer and delay the time to local treatment initiation.

Key Dates

Start date

Apr 28, 2017

Status verified

Mar 2026

Primary completion

Oct 8, 2024

Completion

Oct 8, 2024

Study Design

Enrollment

93 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: active surveillance
  Active surveillance without androgen deprivation
• Experimental: active surveillance with Apalutamide
  Active surveillance during and after 6 months treatment with Apalutamide

Primary Outcome Measure

Time to initiate a local treatment. [ Time Frame: from randomization to local treatment initiation (up to 3 years) ]