Multiple Anti-Cancer Agents for Prostate Cancer

(PROSPECTOR Trial)

Not yet recruiting at 26 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: AstraZeneca
Must be taking: Androgen receptor inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.

Are You a Good Fit for This Trial?

This trial is for adults with prostate cancer that has spread to other parts of the body (metastatic). Participants should be in generally stable health and able to undergo study procedures. People with certain serious medical conditions or who can't safely receive the study drugs may not be eligible.

Inclusion Criteria

Participants must have a minimum life expectancy of 3 months or more
My organs and bone marrow are working well.
Participants must have PCWG3 modified RECIST Version 1.1 evaluable disease
See 10 more

Exclusion Criteria

I have had interstitial lung disease or non-infectious pneumonitis before.
Participants with concurrent serious medical conditions
I still have side effects from previous treatments.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

A dose escalation phase to identify dose limiting toxicities, characterize safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy.

Up to 3 months
Multiple visits for dose escalation and monitoring

Dose Optimization/Expansion (Part B)

A dose optimization/expansion phase to inform recommended Phase 3 dose and explore efficacy with PSA50 rate as primary endpoints.

Up to 3 years 4 months
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year after last dose

What Are the Treatments Tested in This Trial?

Interventions

  • AZD2265 (FPI-2265)
  • AZD2287
  • AZD9574
  • Docetaxel

Trial Overview

The study is testing several anti-cancer treatments, including chemotherapy (Docetaxel), new experimental drugs (AZD9574, AZD2265), and an imaging agent (AZD2287) in people with metastatic prostate cancer. The main goals are to check safety and early effectiveness.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Sub study 1 Part B (SS1B): selected dose of AZD9574 in combination with AZD2265 (FPI-2265)Experimental Treatment3 Interventions
Group II: Sub study 1 Part A (SS1A): escalating dose levels of AZD9574 in combination with AZD2265 (FPI-2265)Experimental Treatment3 Interventions
Group III: SS1B: AZD2265 (FPI-2265) monotherapyExperimental Treatment2 Interventions
Group IV: SS1B: DocetaxelActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology