100 Participants Needed

PSMA PET Scan-Directed Therapy for Prostate Cancer

Recruiting at 1 trial location
RK
HL
NM
PP
Overseen ByPatrick Panlasigui
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well prostate specific membrane antigen (PSMA) or fluciclovine positron emission tomography (PET)/computed tomography (CT) site-directed therapy works for treating patients with prostate cancer. PSMA or fluciclovine PET/CT may detect prostate cancer early and may help to show whether patients benefit from site directed treatment to PET detected abnormalities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is abiraterone acetate safe for humans?

Abiraterone acetate, used with prednisone, is generally considered safe for treating metastatic castration-resistant prostate cancer, though it can cause side effects like low potassium levels, high blood pressure, fluid retention, and liver issues. In clinical trials, serious side effects were relatively rare.12345

What makes the PSMA PET Scan-Directed Therapy with Abiraterone and Prednisone unique for prostate cancer?

This treatment is unique because it uses PSMA PET scans to guide therapy, allowing for precise targeting of prostate cancer cells, and combines abiraterone and prednisone to inhibit androgen production, which fuels prostate cancer growth. This approach is particularly beneficial for patients with metastatic castration-resistant prostate cancer, as it helps assess treatment response and predict overall survival.678910

What data supports the effectiveness of the drug Abiraterone Acetate in treating prostate cancer?

Research shows that Abiraterone Acetate, when combined with prednisone, significantly prolongs survival and delays disease progression in patients with metastatic castration-resistant prostate cancer, compared to a placebo.12111213

Who Is on the Research Team?

AUA University

Evan Yu

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Hemoglobin >= 9 g/dL
Absolute neutrophil count (ANC) >= 1.0 X 10^9/L
I am fully active or restricted in physically strenuous activity but can do light work.
See 13 more

Exclusion Criteria

I have ongoing hepatitis B or C.
Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine or PSMA PET/CT imaging or receive subsequent treatment
I am mentally capable of understanding and giving informed consent.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Patients undergo fluciclovine or PSMA PET/CT to assess the presence of metastatic disease

1 week
1 visit (in-person)

Treatment

Patients receive abiraterone acetate and prednisone, with possible lymphadenectomy or radiation therapy for those with ≤ 3 regions of metastatic disease

24 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

121 weeks
8 visits (in-person)

Long-term Follow-up

Annual follow-up visits to monitor long-term outcomes

Annually after 66 months

What Are the Treatments Tested in This Trial?

Interventions

  • Abiraterone
  • Abiraterone Acetate
  • Prednisone
  • PSMA PET Scan
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Group III (abiraterone, prednisone)Experimental Treatment6 Interventions
Group II: Group II (surgery, radiotherapy, abiraterone, prednisone)Experimental Treatment8 Interventions
Group III: Group I (fluciclovine PET/CT)Active Control3 Interventions

Abiraterone is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Zytiga for:
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Approved in European Union as Zytiga for:
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Approved in Canada as Zytiga for:
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Approved in Japan as Zytiga for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Blue Earth Diagnostics

Industry Sponsor

Trials
43
Recruited
3,100+

Published Research Related to This Trial

In a Swedish observational study of 119 patients with metastatic castration-resistant prostate cancer (mCRPC), abiraterone acetate treatment resulted in similar overall survival rates compared to those seen in the pivotal clinical trial, despite a shorter median treatment duration of 5.6 months versus 7.3 months in the trial.
The findings suggest that while Swedish patients may have characteristics that could limit their treatment benefits, they still achieve comparable survival outcomes, indicating a potentially more cost-effective use of abiraterone in clinical practice.
Value of treatment in clinical trials versus the real world: the case of abiraterone acetate (Zytiga) for postchemotherapy metastatic castration-resistant prostate cancer patients in Sweden.Svensson, J., Andersson, E., Persson, U., et al.[2017]
In a study of 104 patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate, the median overall survival was 16.4 months, highlighting the drug's effectiveness in this patient population.
Key prognostic factors for overall survival included early PSA response (greater than 30% decline at four weeks) and ECOG performance status, suggesting that these metrics can help identify patients who are more likely to benefit from abiraterone acetate treatment.
PSA Kinetics as Prognostic Markers of Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate.España, S., Ochoa de Olza, M., Sala, N., et al.[2022]
Oral abiraterone acetate (Zytiga®) significantly improves overall survival and progression-free survival in patients with metastatic castration-resistant prostate cancer (CRPC) when used with prednisone, compared to a placebo.
The treatment is specifically effective for patients who have already undergone docetaxel-containing chemotherapy, highlighting its role as a subsequent therapy in advanced prostate cancer management.
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer.Scott, LJ., Yang, LPH., Lyseng-Williamson, KA.[2021]

Citations

Value of treatment in clinical trials versus the real world: the case of abiraterone acetate (Zytiga) for postchemotherapy metastatic castration-resistant prostate cancer patients in Sweden. [2017]
PSA Kinetics as Prognostic Markers of Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate. [2022]
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer. [2021]
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary. [2018]
High-Dose Abiraterone Acetate in Men With Castration Resistant Prostate Cancer. [2018]
Pharmacokinetics and bioequivalence of generic and branded abiraterone acetate tablet: a single-dose, open-label, and replicate designed study in healthy Chinese male volunteers. [2022]
Oral formulation strategies to improve the bioavailability and mitigate the food effect of abiraterone acetate. [2020]
Abiraterone acetate: a review of its use in patients with metastatic castration-resistant prostate cancer. [2021]
PSMA-PET Guided Treatment in Prostate Cancer Patients with Oligorecurrent Progression after Previous Salvage Treatment. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
68Ga-PSMA-11 PET Represents the Tumoricidal Effect of 223Ra in a Patient With Castrate-Resistant Metastatic Prostate Cancer. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Lutetium 177 PSMA radionuclide therapy for men with prostate cancer: a review of the current literature and discussion of practical aspects of therapy. [2022]
Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
PSMA PET/CT for Response Assessment and Overall Survival Prediction in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Androgen Receptor Pathway Inhibitors. [2023]
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