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FDG-PET-Guided Radiation Therapy 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

Must not have

Patients who started intensification of therapy beyond ADT (e.g., AR pathway inhibitor, cytotoxic therapy) more than 26 weeks +/- 4 weeks (30 weeks) prior to registration

Patients with prostate cancer that is castration resistant, which is defined as two consecutive rising PSA values despite testosterone level < 50 ng/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I started advanced prostate cancer treatment more than 26 weeks ago.

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My prostate cancer is growing despite low testosterone levels.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete response rate (Cohort 2)

Progression free survival (PFS) (Cohort 1)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Antiandrogen Therapy

2015

Completed Phase 1

~10

Computed Tomography

2017

Completed Phase 2

~2740