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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My PSA levels have been doubling in more than 3 months but less than 18 months.
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My kidney function, measured by creatinine clearance, is adequate.
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My prostate cancer has been confirmed by lab tests.
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My prostate cancer has not spread to other parts as shown by scans.
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I have had radiation therapy to the prostate area after surgery.
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I am 18 years old or older.
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I understand the study details and can consent.
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I have had surgery to remove my prostate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Undetectable PSA (< 0.2 ng/mL) rate
Secondary outcome measures
Median time to reinitiation of antiandrogen therapy (ADT)
Number of patients with PSA < 10 mg/mL and > 3 regions of metastatic prostate cancer on fluciclovine PET/CT
Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL
+3 moreTrial 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
~2370
Abiraterone
2012
Completed Phase 4
~2830
PSMA PET Scan
2020
N/A
~10
Lymphadenectomy
2021
Completed Phase 2
~1480
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2210
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,749 Previous Clinical Trials
1,838,544 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
2,887 Total Patients Enrolled
Evan YuPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
5 Previous Clinical Trials
236 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have ongoing hepatitis B or C.I am fully active or restricted in physically strenuous activity but can do light work.My PSA levels have been doubling in more than 3 months but less than 18 months.I am mentally capable of understanding and giving informed consent.My kidney function, measured by creatinine clearance, is adequate.My bilirubin levels are within the normal range, or I have Gilbert's syndrome with levels up to 3 times the normal.My PSA levels are between 0.2 and 10 ng/mL, confirmed by two tests.I cannot stay still for pictures of my insides.My prostate cancer has been confirmed by lab tests.My prostate cancer has not spread to other parts as shown by scans.I have had radiation therapy to the prostate area after surgery.I am 18 years old or older.I understand the study details and can consent.I have had cancer other than prostate cancer that needed treatment in the last 2 years, except for certain skin and bladder cancers.I have had surgery to remove my prostate.Your doctor believes you have less than 3 months to live.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (fluciclovine PET/CT)
- Group 2: Group II (surgery, radiotherapy, abiraterone, prednisone)
- Group 3: Group III (abiraterone, prednisone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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