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Piflufolastat (18F)

This article discusses a clinical trial that compares two radioactive drugs, Piflufolastat (18F) and Flotufolastat (18F), used in PET imaging for men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy. The study aims to evaluate the effectiveness of these drugs in detecting cancer recurrence and compare their urinary radioactivity levels.

Table of Contents

What is PIFLUFOLASTAT (18F)?

PIFLUFOLASTAT (18F) is a specialized diagnostic drug used in a medical imaging technique called Positron Emission Tomography (PET)[1]. This drug is specifically designed to help doctors detect and monitor prostate cancer, particularly in cases where the cancer might have recurred after initial treatment[1].

How Does PIFLUFOLASTAT (18F) Work?

PIFLUFOLASTAT (18F) works by making cancer cells visible during a PET scan. When injected into the body, it seeks out and attaches to prostate cancer cells. The “18F” in its name refers to a radioactive form of fluorine that’s part of the drug. This radioactive element emits tiny signals that the PET scanner can detect, creating detailed images of where cancer might be present in the body[1].

Current Clinical Trial

A clinical trial is currently underway to study PIFLUFOLASTAT (18F) more closely. This trial is focusing on men who have had their prostate removed (a procedure called radical prostatectomy) but are showing signs that their cancer might have returned[1]. Specifically, the study is looking at patients with low levels of PSA (Prostate-Specific Antigen) in their blood. PSA is a protein that can indicate the presence of prostate cancer when found at elevated levels[1].

Comparison with FLOTUFOLASTAT (18F)

The ongoing clinical trial is comparing PIFLUFOLASTAT (18F) with another similar drug called FLOTUFOLASTAT (18F). Both drugs are used for PET imaging, but researchers want to understand if one might be better than the other in certain aspects[1]. The main focus of this comparison is on how these drugs appear in the urinary system, particularly in the bladder[1].

Potential Benefits for Patients

The research on PIFLUFOLASTAT (18F) could potentially offer several benefits for prostate cancer patients:

  • Early Detection: It may help detect the return of prostate cancer at very early stages, even when PSA levels are still low (0.5 ng/mL or less)[1].
  • Precise Localization: The study aims to determine how well PIFLUFOLASTAT (18F) can identify cancer in specific areas, such as:
    • The area where the prostate used to be before surgery
    • Lymph nodes in the pelvic area
    • Other parts of the body where cancer might have spread[1]
  • Personalized Treatment: By providing detailed images of where cancer cells are located, this technique could help doctors plan more targeted and effective treatments[1].

It’s important to note that while PIFLUFOLASTAT (18F) shows promise, it is still being studied. The ongoing clinical trial will help researchers understand its effectiveness and how it compares to similar diagnostic tools[1].

Aspect Details
Study Type Multi-center, prospective intra-patient comparator study
Participants Men with low PSA (≤0.5 ng/mL) biochemical recurrence after radical prostatectomy
Interventions Piflufolastat (18F) PET and Flotufolastat (18F) PET
Primary Outcome Difference in urinary bladder radioactivity between the two PET scans
Secondary Outcomes Detection rates, stratified detection rates, prostate bed and lymph node detection rates
Study Design Each patient receives both scans, at least 24 hours apart but within 10 days

FAQ

  • What is the purpose of this clinical trial? The trial aims to compare the urinary radioactivity levels between Piflufolastat (18F) and Flotufolastat (18F) PET scans in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy.
  • Who are the participants in this study? The participants are men who have had a radical prostatectomy for prostate cancer and now show signs of biochemical recurrence with low PSA levels (≤0.5 ng/mL).
  • How is the study conducted? Each participant receives a Piflufolastat (18F) PET scan on Day 1, followed by a Flotufolastat (18F) PET scan at least 24 hours later but within 10 days of the first scan.
  • What are the primary outcomes being measured? The main outcome is the difference in urinary bladder radioactivity (measured as mean SUV) between Piflufolastat (18F) and Flotufolastat (18F) PET scans.
  • What are some of the secondary outcomes being assessed? Secondary outcomes include detection rates for cancer recurrence, detection rates based on PSA levels, and detection rates for specific areas such as the prostate bed and pelvic lymph nodes.

Ongoing Clinical Trials on Piflufolastat (18F)

  • Study of AMO959, lutetium (177Lu) vipivotide tetraxetan, and a drug combination for adults with advanced prostate cancer.

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

  • Study of 99mTc-MIP-1404 SPECT/CT imaging compared to standard imaging methods for detecting lymph node metastases in patients with prostate cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study on Lutetium (177Lu) Vipivotide Tetraxetan to Delay Recurrence in Adult Men with PSMA-Positive Oligometastatic Prostate Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +5

  • Study on Metastatic Prostate Cancer: Evaluating [18F]FAPI-74 and Piflufolastat (18F) for Patients with Advanced Disease

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study on the Use of 18F-PSMA-1007, Piflufolastat (18F), and Gozetotide for Detecting Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study Comparing [177Lu]LU-PSMA-I&T and Hormone Therapy for Patients with Metastatic Castration-Resistant Prostate Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study Comparing Darolutamide and Androgen Deprivation Therapy to Placebo and Androgen Deprivation Therapy in Men with High-Risk Prostate Cancer Recurrence

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +8

Glossary

  • PET (Positron Emission Tomography): An imaging test that uses a radioactive drug to show how organs and tissues are functioning in the body.
  • Piflufolastat (18F): A radioactive drug used in PET imaging to detect prostate cancer.
  • Flotufolastat (18F): Another radioactive drug used in PET imaging for prostate cancer detection.
  • PSA (Prostate-Specific Antigen): A protein produced by the prostate gland; elevated levels may indicate prostate cancer.
  • Biochemical Recurrence (BCR): The return of elevated PSA levels after treatment for prostate cancer.
  • Radical Prostatectomy (RP): A surgical procedure to remove the entire prostate gland and surrounding tissues.
  • SUV (Standardized Uptake Value): A measure of radioactivity concentration used in PET imaging.
  • Vesicourethral Anastomosis: The surgical connection between the bladder and the urethra after prostate removal.
  • Retrovesical: Located behind the bladder.
  • Seminal Vesicles: Glands that produce fluid for semen, located near the prostate.

References

  1. https://clinicaltrials.gov/study/NCT06604442