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Radiopharmaceutical

Targeted Radiation + Therapy for Metastatic Prostate Cancer

Phase 2

Recruiting

Led By Nicholas George Nickols, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

PSMA avid metastatic disease as determined by 18F-DCFPyL: at least one lesion with PSMA avidity greater than that of liver (see Prescribing Information for Pluvicto)

Progressive castration resistant prostate cancer as defined by serum testosterone < 50 ng/mL and one of the following:

Must not have

Small cell/neuroendocrine carcinoma by hematoxylin and eosin light histology (immunohistochemical detection of rare/occasional cells that stain for neuroendocrine markers such as synaptophysin, neuron specific enolase, or chromogranin A is not sufficient to make a diagnosis of small cell/neuroendocrine carcinoma)

Symptomatic local recurrence in the setting of prior curative intent therapy (surgery and/or radiation to the prostate)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for metastatic prostate cancer, using radiotherapy, drugs and hormone treatment.

Who is the study for?

Men with advanced prostate cancer that's resistant to hormone therapy can join this trial. They must be fit enough for treatment (ECOG PS 0-2), have metastatic disease confirmed by scans, and agree to use contraception. Men who've had certain treatments or surgeries recently, those with specific other cancers within the last two years, or severe psychiatric issues cannot participate.

What is being tested?

The study is testing if stopping hormone therapy and adding testosterone replacement after targeted radiation therapies can effectively treat advanced prostate cancer. Patients will receive stereotactic ablative radiotherapy and a radiopharmaceutical called Pluvicto; half will also get testosterone replacement.

What are the potential side effects?

Possible side effects include reactions from radiation like skin changes and fatigue, plus potential risks from Pluvicto such as dry mouth, nausea, kidney problems, low blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

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

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My scans show a cancer spot more active than my liver.

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My prostate cancer is worsening despite low testosterone levels.

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I have been treated with specific prostate cancer medications for at least 4 weeks.

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I have 10 cancer spots visible on special scans that can be treated with targeted radiation.

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My cancer has grown or spread according to recent scans.

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I have been diagnosed with prostate cancer, specifically adenocarcinoma.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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My cancer has spread to other parts of my body.

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My scans have shown bone metastases at some point.

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20% of my cancer spread shows on PET scans but not on PSMA scans.

Exclusion Criteria

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

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My cancer is confirmed as small cell/neuroendocrine by specific testing, not just by the presence of certain markers.

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My prostate cancer has returned and is causing symptoms after initial treatment aimed at curing it.

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I need urgent radiation therapy due to spinal cord compression.

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My cancer has spread to my liver or brain, but not my lungs.

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I am currently being treated for an infection with antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to two years

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

Treatment Details

Study Objectives

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

Primary study objectives

6-month radiographic progression-free survival (rPFS)

Secondary study objectives

Objective response rate

Overall survival

PSA30, PSA50, PSA90, maximal PSA response

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment3 Interventions

Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration, followed by restoration of physiologic testosterone

Group II: Arm 1Experimental Treatment2 Interventions

Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

stereotactic ablative radiotherapy

2021

N/A

~10

topical testosterone

2011

Completed Phase 2

~90