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Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT) for Prostate Cancer

Phase 2

Recruiting

Led By David VanderWeele, MD, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have metastatic prostate cancer on conventional imaging (CT scan, MRI, and/or bone scan)

Patients must have mHSPC and be planning therapy with androgen deprivation therapy (ADT), with or without an ARPI, and not planning cytotoxic therapy, to be eligible for Cohort 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial is testing whether using a specific type of imaging scan called FDG-PET to guide radiation therapy, in addition to standard treatments, can be more effective in treating prostate cancer that has spread from

Who is the study for?

This trial is for men with prostate cancer that still responds to hormone therapy and has spread beyond the original site. Participants must be suitable for standard treatments, including antiandrogen therapy and chemotherapy. Specific details on inclusion or exclusion criteria are not provided.Check my eligibility

What is being tested?

The study compares FDG-PET-guided radiation therapy combined with standard treatments against standard treatments alone in metastatic hormone sensitive prostate cancer. The goal is to see if adding targeted radiation improves outcomes.See study design

What are the potential side effects?

Potential side effects may include those from radiation therapy such as fatigue, skin reactions, digestive issues, urinary problems, and sexual dysfunction; plus any associated with standard prostate cancer treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has spread and this was confirmed by scans.

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I have metastatic hormone-sensitive prostate cancer and plan to start hormone therapy without chemotherapy.

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My white blood cell count is healthy for treatment.

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I can lie still for 20 minutes and tolerate specific cancer imaging and radiation treatment.

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I am 18 years old or older.

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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete response rate (Cohort 2)

Progression free survival (PFS) (Cohort 1)

Secondary outcome measures

Incidence of AEs of MDRT (Cohort 2)

Incidence of adverse events (AEs) of metastasis directed radiation therapy (MDRT) (Cohort 1)

Objective response rate (Cohort 2)

+7 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2A (FDG-PET, MDRT, SOC ADT)Experimental Treatment5 Interventions

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

Group II: Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)Experimental Treatment6 Interventions

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial.

Group III: Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)Active Control5 Interventions

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

Group IV: Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)Active Control5 Interventions

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients without PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

Group V: Arm 2B (FDG-PET, SOC ADT)Active Control4 Interventions

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

Group VI: Arm 2C (FDG-PET, SOC ADT)Active Control4 Interventions

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients without PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Radiation Therapy

2017

Completed Phase 3

~7250

Antiandrogen Therapy

2015

Completed Phase 1

~10

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,001 Total Patients Enrolled

20 Trials studying Prostate Cancer

2,959 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,041 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

David VanderWeele, MD, PhDPrincipal InvestigatorNorthwestern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Arm 1A, which includes FDG-PET, MDRT, standard cytotoxic chemotherapy and ADT, received approval from the FDA?

"In line with our assessment criteria, Arm 1A (comprising FDG-PET, MDRT, standard of care cytotoxic chemotherapy & androgen deprivation therapy) has been rated a 2 for safety. This rating reflects the available data supporting its safe use in this Phase 2 trial; however, there is currently no evidence demonstrating efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial

2024. "FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06244004.

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