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Radiopharmaceutical

Targeted Radiation + Therapy for Metastatic Prostate Cancer

Q: Has Arm 1 received clearance from the FDA?

<p>Although the current evidence suggests that Arm 1 is safe, it only received a rating of 2 due to there being no data for efficacy yet.</p>

Q: Are further participants being sought for this experiment?

<p>According to the clinicaltrials.gov portal, this medical study is not recruiting patients at present. The trial was initially posted on November 13th 2023 and last updated October 13th of the same year. However, there are 1,350 other studies with open enrollment currently available for those seeking participation in a clinical trial.</p>

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:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to two years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

My prostate cancer is worsening despite low testosterone levels.

Select...

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

Select...

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

Select...

My cancer has grown or spread according to recent scans.

Select...

I have been diagnosed with prostate cancer, specifically adenocarcinoma.

Select...

I can take care of myself and perform daily activities.

Select...

I am 18 years old or older.

Select...

My cancer has spread to other parts of my body.

Select...

My scans have shown bone metastases at some point.

Select...

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

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

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

Primary outcome measures

6-month radiographic progression-free survival (rPFS)

Secondary outcome measures

Objective response rate

Overall survival

PSA30, PSA50, PSA90, maximal PSA response

+7 more

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

topical testosterone

2011

Completed Phase 2

~90

stereotactic ablative radiotherapy

2021

N/A

~10

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,224 Total Patients Enrolled

14 Trials studying Prostate Cancer

8,725 Patients Enrolled for Prostate Cancer

Nicholas George Nickols, MD PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA

1 Previous Clinical Trials

28 Total Patients Enrolled

Frequently Asked Questions

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

Has Arm 1 received clearance from the FDA?

"Although the current evidence suggests that Arm 1 is safe, it only received a rating of 2 due to there being no data for efficacy yet."

Answered by AI

Are further participants being sought for this experiment?

"According to the clinicaltrials.gov portal, this medical study is not recruiting patients at present. The trial was initially posted on November 13th 2023 and last updated October 13th of the same year. However, there are 1,350 other studies with open enrollment currently available for those seeking participation in a clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

2023. "Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06084338.

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