Registry for Advanced Prostate Cancer

(IRONMAN Trial)

Recruiting at 115 trial locations

Overseen By Jacob Vinson

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Prostate Cancer Clinical Trials Consortium

Disqualifiers: Non-prostate malignancy requiring therapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create a large international registry to gather detailed information on men with advanced prostate cancer. By tracking different treatments and patient outcomes, the research seeks to identify the best treatment sequences and understand how patients respond to various therapies. Men with prostate cancer that has spread to bones or certain lymph nodes, or who have a PSA level over 20 ng/mL at diagnosis, might be a good fit for this study. Participants will provide data and blood samples over several years to help researchers better understand and improve treatment options, including the Standard of Care (also known as Standard Treatment, Conventional Care, or Usual Care). This unphased trial offers participants the opportunity to contribute to a broad understanding of prostate cancer treatment and outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to gather comprehensive data on men with advanced prostate cancer, focusing on both castrate-resistant and hormone-sensitive types. Unlike individual treatment studies, this registry collects information across various standard care treatments, allowing for a deeper understanding of how different therapies perform in real-world settings. By analyzing diverse patient outcomes globally, the trial hopes to identify patterns and insights that could lead to more personalized and effective treatment strategies in the future.

Who Is on the Research Team?

Daniel George, MD

Principal Investigator

Duke Cancer Institute

Lorelei Mucci, ScD

Principal Investigator

Harvard School of Public Health (HSPH)

Phillip Kantoff, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

• Willing and able to provide written informed consent and privacy authorization for the release of personal health information.

NOTE: Privacy authorization may be either included in the informed consent or obtained separately.

Males 21 years of age and above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Detailed data collection from patients at study enrollment, including blood samples and PROMs questionnaires

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for overall survival, adverse events, comorbidities, changes in cancer treatments, and PROMs for a minimum of five years

5 years

Quarterly visits (virtual or in-person)

Biomarker Collection

Collection of blood samples and existing tumor tissue for research on treatment response and resistance

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care

How Is the Trial Designed?

Group I: Hormone Sensitive Prostate Cancer Experimental Treatment 1 Intervention

Group II: Castrate Resistant Prostate Cancer Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Prostate Cancer Clinical Trials Consortium

Lead Sponsor

Trials

12

Recruited

7,400+