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Prostate Cancer Imaging Agent

PyL PET/CT Detection for Metastatic Prostate Cancer (PROSTEP-002 Trial)

Q: How many people are able to enroll in this clinical trial?

Yes, the trial is ongoing and posted on clinicaltrials.gov. The study was created on 3/22/2022 and edited most recently on 3/29/2022; they are looking for 50 patients from 1 location.

Q: Is Enzalutamide capsule a new medication?

Currently, 103 studies involving <a href="https://www.withpower.com/clinical-trials/enzalutamide">Enzalutamide</a> capsules are ongoing with 30 of them in the third phase. Although a majority of these clinical trials originate from Germantown, <a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a>; 5,748 locations worldwide are conducting research on Enzalutamide capsules.

Q: Are there any unfilled study positions that our readers might be able to take advantage of?

That is correct. The website clinicaltrials.gov has the latest information on this trial, which as of today is actively recruiting 50 participants from 1 location.

Q: What sorts of risks does Enzalutamide capsule pose to consumers?

<a href="https://www.withpower.com/clinical-trials/enzalutamide">Enzalutamide</a> capsules are currently in Phase 2 of clinical trials. While there is some evidence suggesting the safety of the medication, more research needs to be conducted to support its efficacy.

Phase 2

Recruiting

Led By Frédéric Pouliot, MD

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

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

Must have

Negative or equivocal findings for prostate cancer on conventional imaging bone scan AND 2) abdomen-pelvis CT/MRI and chest CT or FDG-PET/CT) performed as standard of care workup within 42 days of Day 1(accrual).

Suspected recurrence of prostate cancer based on rising PSA under androgen deprivation therapy. Recurrent castration resistant prostate cancer patients is defined by a rising PSA >1 ng/mL under ADT or surgical castration and with testosterone castration levels < 1.7 nM (PCWG3 criteria).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of study completion, an average of 2 years

Awards & highlights

PROSTEP-002 Trial Summary

This trial looked at how well PyL PET/CT can detect prostate cancer that has spread, in patients who have not yet been treated for it.

Who is the study for?

This trial is for men with untreated castration-resistant prostate cancer who have a life expectancy of at least 6 months, ambiguous or negative imaging results, and rising PSA levels despite hormone therapy. They must be candidates for enzalutamide treatment and able to consent to the study. Men currently on certain medications like finasteride or those who've had recent investigational drug therapy are excluded.Check my eligibility

What is being tested?

The trial is testing how well a diagnostic scan called PyL PET/CT can detect metastases in patients starting on enzalutamide, a medication used for prostate cancer that has resisted other treatments. The performance of this scan will be compared against standard imaging results.See study design

What are the potential side effects?

While the focus of this trial is on the diagnostic performance rather than side effects, enzalutamide itself may cause fatigue, back pain, constipation, joint pain or swelling among others. The PyL PET/CT involves exposure to radiation which carries its own risks.

PROSTEP-002 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My recent scans showed no clear signs of prostate cancer spread.

Select...

My prostate cancer is suspected to have returned because my PSA levels are rising despite hormone therapy.

Select...

I have prostate cancer and am on hormone therapy.

PROSTEP-002 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of study completion, an average of 2 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

Determine the percentage of patients presenting new metastatic lesions detected by 18F-DCFPyL-PSMA PET/CT in castration resistant prostate cancer patients presenting non metastatic, equivocal or oligometastatic (< 5 metastasis) disease

Secondary outcome measures

Determine the intrapatient and interpatient 18F-DCFPyL-PSMA response rates defined by a 50% decrease in intralesional 18F-DCFPyL-PSMA uptake or 50% decrease in sum metastasis 18F-DCFPyL-PSMA uptake after 3 months of enzalutamide.

Other outcome measures

Determine the percentage of patients showing metastatic lesions with enough 18F-DCFPyL uptake (above that of the liver) to justify radioligand therapy before and 3 months after enzalutamide treatment.

Number and sites of new lesions detected by 18F-DCFPyL-PSMA PET/CT at several PSA thresholds

PROSTEP-002 Trial Design

1Treatment groups

Experimental Treatment

Group I: Resistant Prostate Cancer and Negative, Equivocal or Oligometastatic Disease on Conventional ImagingExperimental Treatment1 Intervention

Enrolled subjects will receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL Injection followed by a single PET/CT scan acquired at 1-2 hours post-dosing. After initial 18F-DCFPyL PET/CT, the patients with positive 18F-DCFPyL PET/CT imaging will be treated with enzalutamide (160 mg po id) for M0CRPC disease within less than two weeks. 18F-DCFPyL PET/CT scan will then be repeated 90 days after the start of enzalutamide treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide capsule

2012

Completed Phase 1

~30

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Astellas Pharma Europe Ltd.Industry Sponsor

33 Previous Clinical Trials

72,449 Total Patients Enrolled

2 Trials studying Prostate Cancer

2,315 Patients Enrolled for Prostate Cancer

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

107,107 Total Patients Enrolled

12 Trials studying Prostate Cancer

3,792 Patients Enrolled for Prostate Cancer

Frédéric Pouliot, MDPrincipal InvestigatorCHU de Québec-Université Laval

Frequently Asked Questions

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

How many people are able to enroll in this clinical trial?

"Yes, the trial is ongoing and posted on clinicaltrials.gov. The study was created on 3/22/2022 and edited most recently on 3/29/2022; they are looking for 50 patients from 1 location."

Answered by AI

Is Enzalutamide capsule a new medication?

"Currently, 103 studies involving Enzalutamide capsules are ongoing with 30 of them in the third phase. Although a majority of these clinical trials originate from Germantown, Tennessee; 5,748 locations worldwide are conducting research on Enzalutamide capsules."

Answered by AI

Are there any unfilled study positions that our readers might be able to take advantage of?

"That is correct. The website clinicaltrials.gov has the latest information on this trial, which as of today is actively recruiting 50 participants from 1 location."

Answered by AI

What sorts of risks does Enzalutamide capsule pose to consumers?

"Enzalutamide capsules are currently in Phase 2 of clinical trials. While there is some evidence suggesting the safety of the medication, more research needs to be conducted to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.

2022. "Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04655365.

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