← Back to Search

Androgen Receptor Inhibitor

PSMA PET Scan-Directed Therapy for Prostate Cancer

Phase 2

Recruiting

Led By Evan Yu

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

PSA doubling time must be calculated utilizing either all PSA measurements > 0.1 ng/mL from most recent biochemically-recurred (BCR) or the most recent 3 PSA measurements > 0.1 ng/mL (if the latter, all 3 PSA measurements must be > 2 weeks apart to be used in the calculation). PSA doubling time must be > 3 months and < 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used

Must not have

Chronic active hepatitis B or C

Any condition that would alter the patient's mental status, prohibiting understanding and/or authorization of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well a PET scan using fluciclovine helps to detect prostate cancer and if site-directed treatment to abnormalities found on the scan works well for treating patients with prostate cancer.

Who is the study for?

Men who've had prostate surgery and radiation, with a recent PSA level between 0.2-10 ng/mL that's rising, but no visible metastasis on scans. They should be relatively healthy (ECOG 0 or 1), have certain blood levels within range, and not have other serious illnesses or recent cancers besides non-melanoma skin cancer.

What is being tested?

The trial is testing if targeted therapy directed by PSMA or fluciclovine PET/CT scans can effectively treat prostate cancer recurrences. It involves drugs like Abiraterone Acetate with Prednisone, potential lymph node removal, and possibly radiation based on scan results.

What are the potential side effects?

Possible side effects include fatigue, joint swelling/pain from Abiraterone; increased appetite, weight gain from Prednisone; discomfort during the PET/CT scan; surgical risks from lymphadenectomy; and typical radiation therapy side effects like skin irritation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My PSA levels have been doubling in more than 3 months but less than 18 months.

Select...

My kidney function, measured by creatinine clearance, is adequate.

Select...

My prostate cancer has been confirmed by lab tests.

Select...

My prostate cancer has not spread to other parts as shown by scans.

Select...

I have had radiation therapy to the prostate area after surgery.

Select...

I am 18 years old or older.

Select...

I understand the study details and can consent.

Select...

I have had surgery to remove my prostate.

Exclusion Criteria

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

Select...

I have ongoing hepatitis B or C.

Select...

I am mentally capable of understanding and giving informed consent.

Select...

I cannot stay still for pictures of my insides.

Select...

I have had cancer other than prostate cancer that needed treatment in the last 2 years, except for certain skin and bladder cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group III (abiraterone, prednisone)Experimental Treatment6 Interventions

Patients undergo fluciclovine or PSMA PET/CT and who have \> 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II.

Group II: Group II (surgery, radiotherapy, abiraterone, prednisone)Experimental Treatment8 Interventions

Patients undergo fluciclovine or PSMA PET/CT and who have =\< 3 regions of metastatic disease outside of the prostatic fossa that are amenable to metastasis-directed therapy undergo lymphadenectomy or radiation therapy. Six to ten weeks after surgery, patients receive abiraterone acetate 1000 mg PO QD and prednisone PO QD. Treatment repeats every 4 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may start radiation therapy after 2 cycles of abiraterone acetate and prednisone.

Group III: Group I (fluciclovine PET/CT)Active Control3 Interventions

Patients for whom initial fluciclovine or PSMA PET/CT does not reveal any abnormalities outside the prostatic fossa undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is \> 2 ng/ml. If still no abnormalities are found outside of the prostatic fossa, patients continue to undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is \> 5 ng/ml. Patients are off study for treatment plan once PSA reaches 10 ng/ml.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone Acetate

2015

Completed Phase 4

~1880

Prednisone

2014

Completed Phase 4

~2500