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Study on the Effect of Metastasis-Directed Therapy with Lutetium (177Lu) Zadavotide Guraxetan in Patients with Advanced Prostate Cancer and Up to 5 Progressive Lesions

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What is this trial about?

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

This clinical trial is focused on studying a type of prostate cancer known as castration-refractory prostate cancer, which continues to progress despite treatments that lower testosterone. Specifically, the trial is looking at cases where the cancer has spread to a limited number of new areas, referred to as oligoprogressive metastatic castration-refractory prostate cancer. The purpose of the study is to determine if adding a treatment that targets these new cancerous areas, called metastasis-directed therapy, can help patients live longer compared to the usual care.

The study involves several medications that are already used in treating prostate cancer. These include 177Lu PSMA I&T, a solution for injection; Xofigo, another injectable solution; Talzenna, which comes in capsule form; NUBEQA, ZYTIGA, Xtandi, Lynparza, and Erleada, all of which are film-coated tablets; JEVTANA and TAXOTERE, which are solutions for infusion; and Akeega, a combination of two substances in tablet form. Some of these medications are given by injection or infusion, while others are taken orally as tablets or capsules.

Participants in the study will receive either the standard treatment or the standard treatment plus the additional metastasis-directed therapy. The study will follow participants over time to see how long they live and to monitor their quality of life. The trial will also look at how the cancer responds to the treatments and any side effects that may occur. The goal is to gather information that could improve treatment strategies for this type of prostate cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, you will be randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.
Step 2
Treatment administration
Depending on the group you are assigned to, you will receive specific treatments. These may include medications such as Talzenna (0.25 mg capsules taken orally), NUBEQA (300 mg tablets taken orally), ZYTIGA (500 mg tablets taken orally), Xtandi (40 mg tablets taken orally), Lynparza (150 mg tablets taken orally), Erleada (60 mg tablets taken orally), or Akeega (100 mg/500 mg tablets taken orally).
Some treatments may be administered through injections or infusions, such as 177Lu PSMA I&T solution for injection, Xofigo solution for injection, JEVTANA solution for infusion, or TAXOTERE concentrate for infusion.
The frequency and duration of these treatments will be determined by the study protocol and your healthcare provider.
Step 3
Follow-up consultations
You will have regular follow-up consultations to monitor your health and the effects of the treatment. These consultations are planned at the start of the study and then at months 1, 3, 6, 12, and 24.
During these visits, your quality of life will be assessed using specific questionnaires, and any side effects or symptoms will be recorded.
Step 4
Imaging assessments
Imaging tests, such as PSMA PET-CT scans, will be performed every 6 months or if there are any signs of disease progression. These tests help in evaluating the response to the treatment and any changes in your condition.
Step 5
End of trial
The trial is expected to continue until July 2029. Your participation may end earlier if you choose to withdraw or if your healthcare provider decides it is in your best interest to stop the treatment.

Who can join the trial?

10 criteria

The patient must provide voluntary written informed consent, or their legally authorized representative must do so, before any screening procedures.
The patient must have a type of prostate cancer called acinar adenocarcinoma, which may include a variation known as neuro-endocrine dedifferentiation.
The patient must use highly effective birth control methods, which means methods that have a very low chance of failure (less than 1% per year) when used correctly. This includes complete abstinence from heterosexual intercourse, using condoms, having a vasectomy, or having a partner who uses implants, injectables, combined oral contraceptives, or certain IUDs. This must continue for at least 6 months after the last dose of the trial treatment.
The patient must have oligoprogressive disease, which means having a maximum of 5 areas of cancer growth outside the brain. This can be existing areas, new areas, or both, as reported by specific imaging standards. If there is persistent or returning disease in the local area, additional imaging tests like MRI or CT scans may be needed. There are two groups of patients eligible: those with ongoing treatment of pADT only (Type 1) and those with pADT plus or minus second-line systemic therapy, including those who had received docetaxel in the past (Type 2).
The patient must have castration-refractory disease, which means a testosterone level below 50 ng/dL or 1.7 nmol/L, along with signs of cancer progression either through tests or imaging.
The patient must have had prior treatment of the primary tumor through radiotherapy or surgery. If not, local therapy should be added to the treatment along with metastasis-directed therapy (MDT).
The patient must have a WHO performance status of 0 to 2, which is a measure of their ability to perform daily activities.
The patient must be 18 years or older.
The patient must not have any psychological, sociological, or geographical conditions that could prevent them from following the study protocol.
The patient must be presented at a multidisciplinary board meeting, and their inclusion in the trial must be approved by this board.

Who cannot join the trial?

3 criteria

Patients who do not have oligoprogressive metastatic castration-refractory prostate cancer cannot participate. This means the cancer has spread to a few places and does not respond to treatments that lower testosterone.
Only male patients can participate in this study.
Patients who are part of a vulnerable population cannot participate. This usually refers to groups who may need special protection, like children or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
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Katholieke Universiteit te Leuven
Leuven, Belgium
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Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

Metastasis-directed therapy is a treatment approach used in this clinical trial. It focuses on targeting and treating specific areas where cancer has spread, known as metastases. The goal of this therapy is to directly address and eliminate these cancerous spots, potentially improving the patient's overall survival. This approach is being tested to see if it can be more effective than the usual treatments for patients with a specific type of prostate cancer that has become resistant to standard hormone therapy.

What is already known about the treatment

Metastasis-directed therapy – This treatment is administered to patients with a specific type of prostate cancer that has spread to a few other parts of the body and is resistant to standard hormone therapy. The therapy is currently being studied in clinical trials to determine if it can help patients live longer compared to usual treatments. It is mainly used for patients with oligoprogressive metastatic castration-refractory prostate cancer. The treatment works by targeting and treating the cancerous areas that have spread, potentially slowing down the disease's progression. It falls under the category of targeted cancer therapies, which aim to specifically attack cancer cells while minimizing damage to normal cells.

Investigated diseases

Oligoprogressive metastatic castration-refractory prostate cancer – This disease is a form of prostate cancer that continues to progress despite treatments that lower testosterone levels, which are typically used to control prostate cancer growth. It is characterized by the presence of a limited number of metastatic sites, meaning the cancer has spread to a few other parts of the body. The progression of the disease involves the cancer cells becoming resistant to hormonal therapy, which is initially effective in controlling the disease. Over time, the cancer may spread to bones, lymph nodes, or other organs, leading to further complications. The disease is monitored through imaging techniques to track the spread and growth of cancerous lesions. As the disease advances, patients may experience symptoms related to the spread of cancer, such as pain or urinary issues.