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Evaluation of PIFLUFOLASTAT (18F) PET/CT for monitoring prostate cancer recurrence in patients with favourable intermediate‑risk localized disease after focal HIFU

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on men with prostate cancer that is classified as favourable intermediate‑risk and has been treated with HIFU (high‑intensity focused ultrasound, a method that uses concentrated sound waves to destroy the tumor). After the treatment, a special imaging test called PSMA PET/CT will be performed using the tracer PIFLUFOLASTAT (18F). This test works by attaching a tiny amount of a radioactive substance to a molecule that seeks out prostate cancer cells, allowing a scanner to create pictures of any remaining disease. For comparison, a multiparametric MRI (an MRI scan that uses several different settings to give a detailed view of the prostate) will also be done, and if the scans suggest the cancer has returned, a small tissue sample will be taken through a biopsy to confirm.

The purpose of the study is to evaluate how well the PSMA PET/CT scan can detect cancer recurrence one year after HIFU treatment. Participants will have the imaging tests at the one‑year follow‑up, and any suspicious areas will be checked with a biopsy, which serves as the reference standard. The results will be collected to determine the accuracy of the imaging methods.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Receive tracer injection
piflufolastat (18f) is a radioactive substance used for imaging. a dose of 360 mbq (megabecquerel, a unit of radioactivity) is given through an intravenous (iv) injection or infusion. the injection is performed in a clinical setting before the imaging procedure.
Step 2
Undergo psma pet/ct scan
Shortly after the injection, a psma pet/ct scan is performed. this scan combines a positron emission tomography (pet) that detects the radioactive tracer with a computed tomography (ct) that provides detailed body images. the purpose is to look for signs of prostate cancer recurrence.
Step 3
Wait for one‑year follow‑up period
After the initial scan, the study continues for a period of one year. no specific actions are required during this time unless instructed by the clinical team.
Step 4
Return for repeat psma pet/ct scan
Approximately one year after the first scan, the same procedure is repeated. a second dose of 360 mbq piflufolastat (18f) is injected, followed by another psma pet/ct scan to assess any changes.
Step 5
Undergo multiparametric mri
On the same follow‑up visit, a multiparametric magnetic resonance imaging (mri) exam is performed. this is a detailed imaging test that uses magnetic fields to create pictures of the prostate and surrounding tissue.
Step 6
Undergo prostate biopsy
After the imaging tests, a prostate biopsy is performed. a small sample of prostate tissue is taken with a needle and examined in a laboratory. the biopsy result serves as the reference standard for confirming whether cancer has recurred.

Who can join the trial?

8 criteria

Must have been diagnosed with prostate cancer, a type of cancer that starts in the prostate gland.
Must be at least 70 years old.
Must have a life expectancy (the expected number of years to live) of more than 5 years.
Clinical tests must show a clinical stage of T1c to T2a (early stage tumors that are confined to the prostate) and a blood level of PSA (a protein that can indicate prostate activity) lower than 20 ng/ml.
Biopsy results must show a single area with a grade called ISUP 2 in no more than two adjacent sections of the prostate (called sextants), with or without a smaller area of grade ISUP 1 on the same side (ipsilateral) or opposite side (contralateral); if more than one area is found, only one may be ISUP 2.
Imaging must reveal only one abnormal spot (single lesion) that is scored as PIRADS 3, 4, or 5 (a system that rates the likelihood of cancer on MRI) and the prostate must be smaller than 150 ml in volume.
Must be enrolled in a social security scheme (a government‑run health insurance program).
Must sign a clear and voluntary informed consent form indicating understanding of the study.

Who cannot join the trial?

7 criteria

Having signs that the cancer has spread outside the prostate (extraprostatic extension) or has entered the tiny tubes that help make semen (seminal vesicles).
Being in jail, prison, or under legal care where another person makes legal decisions for you (legal guardianship).
Any health problem that makes it difficult for you to understand the study, follow the study instructions, could increase your risk, or could affect the study results.
Being allergic (hypersensitivity) to the study drug called 18F-PSMA or to any of its inactive ingredients (excipients).
Being unable to have an MRI scan because of a condition that makes MRI unsafe (contraindications), such as having metal devices inside your body (internal metal devices).
Having moderate to severe kidney disease, shown by a kidney function test called eGFR that is 60 mL/min or lower.
Having severe liver disease (liver failure).

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Verified sites

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Oncopole Claudius Regaud
Verified
Toulouse, France

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Investigated drugs

PIFLUFOLASTAT (18F)
is a special radioactive substance that doctors inject into a vein before a PET/CT scan. It travels through the bloodstream and sticks to prostate cancer cells that have a protein called PSMA. Because it gives off a tiny amount of radiation, the PET scanner can see where the cancer cells are and help doctors determine if the cancer has come back after treatment.
Focal HIFU (High‑Intensity Focused Ultrasound)
is a non‑surgical therapy that uses very focused sound waves to heat and destroy a small, targeted area of prostate tissue that contains cancer. In this study, it is used as the first‑line curative treatment for men with intermediate‑risk localized prostate cancer, and the researchers are checking how well it works by looking for any cancer that might return later.

What is already known about the treatment

PIFLUFOLASTAT (18F) - It is given by intravenous injection or infusion, delivering a small amount of radioactive tracer (360 MBq) into the bloodstream. The tracer is approved for use in PET imaging and is widely described in medical literature as a diagnostic agent for prostate cancer. It helps doctors see prostate cancer cells that have a protein called PSMA, because the radioactive part binds to that protein and shows up on the PET scan. PIFLUFOLASTAT (18F) belongs to the class of radiopharmaceuticals used for diagnostic imaging.

Investigated diseases

Prostate cancer - Prostate cancer is a growth of abnormal cells in the prostate gland, which is part of the male reproductive system. It often begins as a small, localized tumor that may not cause noticeable symptoms. Over time, the tumor can enlarge and invade nearby tissues within the prostate. In some cases, cancer cells may spread to surrounding structures such as the seminal vesicles or nearby lymph nodes. The disease may progress slowly, allowing it to remain confined for years, or it can grow more rapidly, increasing the area of involvement within the pelvic region.