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Completed

NCT Number: NCT02346578

Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.

The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.

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Key information

Conditions

Castration-resistant Prostate Cancer

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Osaka City University Graduate School of Medicine

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Testosterone of less than 50 ng/dL
  • Participants who was detected of disease progression on image or relapse of PSA (All PSA values measured 3 time at least one week interval are consecutively increased and final value is 2 ng/mL or more. If third value is not higher than second one, fourth measurement will be undertaken and its value must be higher than second one.)
  • Participants who relapsed after CAB with bicalutamide
  • Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
  • Aged 20 years or older
  • Participants who provided written informed consent

Exclusion criteria

  • Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy
  • With active double cancer
  • Any prior treatment with bicalutamide within 6 weeks
  • Participants who received systemic biological therapy (except for existing approved drug for bone or treatment with luteinizing hormone-releasing hormone (LHRH) analogue) or received treatment with other antitumor agent for prostate cancer
  • With serious complication
  • History of hypersensitivity to enzalutamide or any other excipient of enzalutamide
  • History of hypersensitivity to flutamide-containing agent
  • With liver dysfunction
  • Participants who are considered as inadequate by the investigator

Treatment and study plan

Enzalutamide

Drug

flutamide

Drug

Primary outcomes

  1. Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3

    Time frame: Month 3

Secondary outcomes

  1. Percentage of participants whose PSA decreased 50 percent or more at month 6

    Time frame: Month 6

  2. Percentage of participants who showed disease progression at month 3

    Time frame: Month 3

  3. Percentage of participants who showed disease progression at month 6

    Time frame: Month 6

  4. PSA progression-free survival (PFS)

    Time frame: Up to 39 months

  5. QOL measured by functional assessment of cancer therapy-prostate (FACT-P)

    Time frame: Up to 39 months

Sponsors and collaborators

Lead sponsor

Taro Iguchi, MD, PHD

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jan 27, 2015
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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