🏛️ Verified NIH Record • Updated 2026-08-25

Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (NCT05367440)

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD5305 when given in combination with new hormonal agents (NHAs) in patients with Metastatic Prostate Cancer.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (33 items).

Location: Research Site — Detroit, Michigan

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria: For Part A mCRPC patients only:
  • Any previous treatment with a new hormonal agent (NHA), poly (adenosine diphosphateribose) polymerase inhibitor (PARPi), Lutetium prostate-specific membrane antigen (Lu-PSMA), platinum chemotherapy
  • Patients recruited to the PDc cohorts should not have received a prior use of new hormonal agents (NHA). For Part A and Part B mCSPC Patients:
  • Any previous treatment with a PARPi, platinum, NHA, Immuno-oncology (IO), radiopharmaceutical therapy, or prior treatment with docetaxel in mCSPC setting.
  • Concomitant use of medications or herbal supplements known to be:
  • Strong and moderate CYP3A4 inducers/inhibitors (applies for all arms)
  • For Arm 1 (enzalutamide) patients: Strong CYP2C8 inhibitors
  • For Arm 3 (darolutamide) patients: Strong P-glycoprotein inducers
  • Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
  • Treatment with any of the following:
  • Any investigational agents or study interventions from a previous clinical study within 5 half lives or 3 weeks (whichever is longer) of the first dose of study treatment.
  • Any other anticancer treatment within the following time periods prior to the first dose of study treatment: (i) Cytotoxic and non-cytotoxic treatment: 3 weeks or 5 half-lives (whichever is shorter). (ii) Biological products including immuno-oncology agents: 4 weeks before enrolment.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (20 Sites)

  • Research Site — Detroit, Michigan
  • Research Site — Detroit, Michigan
  • Research Site — Syracuse, New York
  • Research Site — Myrtle Beach, South Carolina
  • Research Site — Houston, Texas
  • Research Site — Houston, Texas
  • Research Site — Camperdown,
  • Research Site — Darlinghurst,
  • Research Site — East Melbourne,
  • Research Site — Heidelberg,
  • Research Site — Melbourne,
  • Research Site — St Leonards,
  • Research Site — Candiolo,
  • Research Site — Milan,
  • Research Site — Orbassano,
  • Research Site — Padova,
  • Research Site — Cambridge,
  • Research Site — Glasgow,
  • Research Site — Manchester,
  • Research Site — Plymouth,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗