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RecruitingLast updated: 8 November 2023

LIBERTAS: This study is evaluating the effectiveness of either continuous or intermittent androgen-deprivation therapy when given in combination with apalutamide in people with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) responseA Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two experimental treatment arms.

In Experimental Arm A, participants with prostate-specific antigen (PSA) level <0.2ng/mL afeter 6 months of treatment with Apalutamide and Adrogen-Deprivation Therapy (ADT) during the initial treatment phase will enter the main treatment phase and be treated with apalutamide with intermittent ADT per protocol or followed up for at least 18 months from Day 1 of Cycle 7.

In Experimental Arm B, participants with PSA level <0.2ng/mL after 6 months of treatment with apalutamide and ADT during initial treatment phase will enter the main treatment phase and continue to receive apalutamide plus continious ADT or followed up for at least 18 months from Day 1 of Cycle 7.

Conditions

This trial is treating patients with metastatic castrate-sensitive prostate cancer (mCSPC)

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

LIBERTAS

More information

Trial Identifiers

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Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Eligibility

Inclusion

  • Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI] demonstrating greater than equal (>=) 2 distinct extraprostatic sites of metastasis
  • Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
  • A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
  • Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
  • Assigned male at birth, inclusive of all gender identities
  • Participants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care

Exclusion

  • History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
  • Pelvic lymph nodes as only site of metastasis
  • Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
  • Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
  • Gastrointestinal disorder affecting absorption

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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