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RecruitingLast updated: 26 February 2024

EvoPar-Prostate01: The intention of this study is to demonstrate that targeted therapy (called Saruparib) in addition to hormone therapy is more effective than hormone therapy alone in people with metastatic castration-sensitive prostate cancer (mCSPC)A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer

Clinical summary

Summary

This study is recruiting people with HRRm and Non-HRRm metastatic castration-sensitive prostate cancer (mCSPC). Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive oral targeted therapy (called Saruparib) in addition to physician's choice of new oral hormone agents (either Abiraterone, Darolutamide, or Enzalutamide).

In the Placebo Comparator Arm, participants will receive an oral placebo in addition to physician's choice of new oral hormone agents (either Abiraterone, Darolutamide, or Enzalutamide). 

Conditions

This trial is treating patients with metastatic castration-sensitive prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18 - 130

Phase

III

Trial Acronym

EvoPar-Prostate01

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific Title

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer

Eligibility

Inclusion

  • Male ≥ 18 years of age
  • Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
  • Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
  • Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to randomisation
  • ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
  • Provision of FFPE tumour tissue sample and blood sample (for ctDNA)
  • Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to

determine cohort eligibility

  • Adequate organ and bone marrow function as described in study protocol
  • Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
  • Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion

  • Participants with a history of MDS/AML or with features suggestive of MDS/AML
  • Participants with any known predisposition to bleeding
  • Any history of persisting (> 2 weeks) severe cytopenia
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
  • History of another primary malignancy, with exceptions
  • Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
  • Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention
  • Cardiac criteria, including history of arrythmia and cardiovascular disease
  • Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions:
  • Prior treatment within 14 days with blood product support or growth factor support.
  • Participants who are unevaluable for both bone and soft tissue progression

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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

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