152 Participants NeededMy employer runs this trial

Multiple Anti-Cancer Agents for Prostate Cancer

(PROSPECTOR Trial)

Recruiting at 29 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?

This trial tests the safety and effectiveness of different anti-cancer drugs for individuals with advanced prostate cancer that has spread. Participants will receive either a combination of two experimental drugs, one experimental drug alone, or a standard treatment called docetaxel, a chemotherapy drug. The trial seeks individuals with confirmed prostate cancer that has spread and no longer responds to standard hormone treatments. This study helps researchers understand the effectiveness of these new treatments and how patients tolerate them. As a Phase 1 and Phase 2 trial, it focuses on understanding the treatment's effects and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does require that you have ongoing androgen deprivation therapy and a castrate level of serum testosterone. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found the combination of AZD9574 and AZD2265 to be generally safe. Most patients tolerated the drugs well, even at higher doses. Although some patients experienced side effects, these were mostly mild, suggesting the combination is usually safe for patients.

Early research on AZD2265 alone shows it is also well-tolerated. Most patients did not experience serious side effects, even those with extensive prior treatments, indicating AZD2265 is likely safe for many people.

Overall, studies so far have shown both treatments to be safe, as they have not caused many serious problems for patients. However, individual experiences with any treatment can vary.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments in this trial because they explore new combinations and applications of anti-cancer agents for prostate cancer. Unlike the standard treatment, which typically includes chemotherapy drugs like docetaxel, these investigational therapies include AZD9574 and AZD2265, which are administered in novel combinations. AZD9574 offers a unique mechanism by being taken daily alongside AZD2265, which could enhance its effectiveness. Additionally, AZD2265 is being tested both in combination and as a monotherapy, potentially providing more personalized treatment options. This trial could uncover more effective strategies by targeting cancer cells in different ways than traditional chemotherapy.

What evidence suggests that this trial's treatments could be effective for metastatic prostate cancer?

This trial will evaluate multiple anti-cancer agents for prostate cancer. Participants may receive a combination of AZD9574 and AZD2265, which studies have shown might help treat prostate cancer. Early lab tests demonstrated that these drugs work well together, showing strong effects against cancer. Another treatment arm will assess AZD2265 alone, which research suggests could be beneficial. Specifically, one study showed that AZD2265 helped some patients with advanced prostate cancer by shrinking their tumors and slowing disease progression. These findings suggest possible benefits for patients with metastatic prostate cancer, but further research is needed to confirm these results.14567

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: Substudy 1 Part A(SS1A): escalating dose levels of palacaparib in combination with AZD2265(FPI-2265)Experimental Treatment3 Interventions
Group II: Sub study 1 Part B(SS1B): selected dose of palacaparib 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

Citations

A Clinical Evaluation of Enzalutamide in Metastatic Castration ...

PSA response to second-line therapy occurred in 36% patients for enzalutamide and 4% for AA (χ2 p<0.0001). There was a trend toward superior OS in the ...

PSMA-Directed Targeted Alpha Therapy Shows Activity in ...

Further, among those evaluable by RECIST 1.1 criteria (n = 9), 33% of patients achieved a partial response, 44% had stable disease, and 22% ...

Preliminary efficacy and safety results from the (TATCIST) trial ...

Preliminary efficacy and safety data as of 30Jan24 suggest that FPI-2265 is active in heavily pretreated pts with progressive mCRPC, including pts who received ...

FPI-2265 for Metastatic Prostate Cancer (AlphaBreak Trial)

The treatment also demonstrated promising overall survival rates of 81% and a median progression-free survival of 12 months, while maintaining low toxicity, ...

NCT06402331 | FPI-2265 (225Ac-PSMA-I&T) for Patients ...

The purpose of the study is to determine the safety and tolerability, and recommended dose and regiment of FPI-2265.

FPI-2265 / AstraZeneca

FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P2 | N=85 | Active, ...

Fusion Pharmaceuticals Announces Presentation of Interim ...

Preliminary data demonstrate FPI-2265 is active in heavily pretreated patients with progressive metastatic castration-resistant prostate cancer (mCRPC).