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

3 1 1 1

What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as oligometastatic prostate cancer, which is a form of cancer that has spread to a limited number of other parts of the body. The study is investigating the effects of a treatment called lutetium (177Lu) vipivotide tetraxetan, also known by its code name AAA617. This treatment is compared to simply observing the patients without any active treatment to see if it can delay the return of the disease or the need for further treatment.

The trial involves adult male patients who have prostate cancer that shows positive results for a specific marker called prostate-specific membrane antigen (PSMA). The study uses a special type of imaging called Positron Emission Tomography (PET) to identify the presence of PSMA in the cancer. Patients will receive either the treatment or be placed under observation, and their progress will be monitored over time to see how the treatment affects the spread of cancer.

Participants in the study will undergo regular imaging tests, such as CT or MRI scans, to track the presence of cancer in the body. The main goal is to determine how long patients can remain free from new cancer growth or the need for additional treatment. The study will also look at other factors, such as the time it takes for the cancer to progress and the overall health and quality of life of the participants. The trial is expected to continue until 2030, with recruitment starting in 2024.

1 joining the study

Upon joining the study, participation is confirmed through a process called randomization. This means being assigned to one of two groups: one receiving the treatment and the other under observation.

2 treatment administration

If assigned to the treatment group, the medication lutetium (177Lu) vipivotide tetraxetan is administered. This is given as a solution for injection or infusion through a vein (intravenous use).

The dosage and frequency of administration are determined by the study protocol and medical team.

3 observation period

Participants in the observation group do not receive the study medication but are monitored for any changes in their condition.

4 regular assessments

Throughout the study, regular assessments are conducted to monitor health status. These include imaging tests like CT or MRI scans and bone scans to check for any new metastasis or changes in existing conditions.

Blood tests are performed to measure prostate-specific antigen (PSA) levels, which help in assessing disease progression.

5 safety monitoring

Safety is closely monitored by tracking any side effects or adverse events. This includes changes in laboratory values, vital signs, and electrocardiograms (ECGs).

Any significant changes are recorded and addressed by the medical team.

6 end of study

The study is expected to conclude by June 3, 2030. At this point, final assessments are conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of prostate cancer through a tissue sample test before joining the study.
  • Must have prostate cancer that has returned after initial treatment, which could include surgery, radiation, or brachytherapy. This return is shown by specific levels of a protein called PSA in the blood.
  • Must have a type of prostate cancer called oligometastatic prostate cancer (OMPC), which means having 5 or fewer cancer spots that show up on a special scan called PSMA PET/CT.
  • At least one of these cancer spots must be a distant metastasis, meaning it has spread to a part of the body far from the original cancer site.
  • Must have a negative result on regular imaging tests for cancer that has spread far from the prostate. This means the tests should not show clear signs of cancer spread.
  • All cancer spots found during screening should be treatable with a type of radiation therapy called SBRT.
  • Must have a testosterone level higher than 100 ng/dL, which means the body is producing normal levels of this hormone.
  • Only male participants are eligible for this study.

Who Cannot Join the Study?

  • Only male participants can join the study. Female participants are not eligible.
  • Participants must have oligometastatic prostate cancer (OMPC). This means the cancer has spread to a few other parts of the body.
  • Participants must be adults. This means they should be 18 years or older.
  • The study is not open to vulnerable populations. This means people who might need special protection or care are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Jean Perrin Clermont Ferrand France
Bellvitge University Hospital L'hospitalet De Llobregat Spain
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Rostock University Medical Center Rostock Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium

Other Sites

Site Name City Country Status
Centre Henri Becquerel Rouen France
Narodny Onkologicky Ustav Bratislava Slovakia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
University Hospital Olomouc Olomouc Czechia
Universitaetsklinikum Aachen AöR Aachen Germany
Orszagos Onkologiai Intezet Budapest Hungary
University Of Debrecen Debrecen Hungary
Virgen del Rocío University Hospital Sevilla Spain
Alexandra Hospital Athens Greece
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Gasthuiszusters Antwerpen Antwerp Belgium
Hospices Civils De Lyon Lyon France
Semmelweis University Budapest Hungary
Netherlands Cancer Institute Amsterdam The Netherlands
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Universitair Ziekenhuis Gent Gent Belgium
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Hospital Universitario 12 De Octubre Madrid Spain
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Fundacio Puigvert Barcelona Spain
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Hospital Universitario Virgen De Las Nieves Granada Spain
Privatna Urologicka Ambulancia s.r.o. Trencin Slovakia
Institut Curie – Site Saint-Cloud Saint-Cloud France
Institut de Cancérologie de l’Ouest Saint-Herblain France
University Hospital Ostrava Ostrava Czechia
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Uroexam spol. s r.o. Nitra Slovakia
Uqphkavlrqkwkaoowyieb Mmbhhptk Ava Munster Germany
Uloiwuwdqeknxnuwvljfu Ajfwrwzi Augsburg Germany
Tdjxczbcbd Cxwrvw Hsetllbk Thessaloniki Greece
Uaudqfuopm Hpbftghr Cttljbn Cologne Germany
Fbxjtzhr nmybdzcro Mjnkp a Huaewpx Prague Czechia
Kpfwkhwh drp Uusqirqmfsce Mrlyuiwj Anh Munich Germany
Ujyfvzpqedxqeifqwgznu Ekppu Ahm Essen Germany
Ogzycidiiqvjwy Lhza Gjhz Linz Austria
Irdapgmq Clqbv Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
24.06.2024
Belgium Belgium
Recruiting
24.06.2024
Czechia Czechia
Recruiting
24.06.2024
France France
Recruiting
24.06.2024
Germany Germany
Recruiting
24.06.2024
Greece Greece
Recruiting
24.06.2024
Hungary Hungary
Recruiting
24.06.2024
Italy Italy
Recruiting
24.06.2024
Slovakia Slovakia
Recruiting
24.06.2024
Spain Spain
Recruiting
24.06.2024
The Netherlands The Netherlands
Recruiting
24.06.2024

Trial locations

Lutetium (177Lu) vipivotide tetraxetan (AAA617) is a medication being studied for its potential to delay the progression of prostate cancer in men. It is used in patients with a specific type of prostate cancer that shows positive results on a PSMA PET scan. This medication works by delivering targeted radiation to cancer cells, which may help to slow down or stop the growth of the cancer.

Oligometastatic Prostate Cancer – Oligometastatic prostate cancer is a form of prostate cancer where the disease has spread beyond the prostate gland but is limited to a few metastatic sites, typically fewer than five. This condition represents an intermediate state between localized prostate cancer and widespread metastatic disease. The cancer cells may spread to bones or other soft tissues, but the number of these metastatic sites is relatively small. The progression of oligometastatic prostate cancer can vary, with some cases remaining stable for extended periods, while others may progress to more widespread metastasis. The disease is often monitored through imaging techniques such as CT scans, MRIs, and bone scans to assess the extent and progression of metastasis.

Trial ID:
2022-502956-29-00
Protocol code:
CAAA617D12302
NCT ID:
NCT05939414
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Docetaxel and Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Have a Deep PSA Response After Initial Apalutamide Treatment

    Recruiting

    3 1 1 1
    Investigated drugs:
    France Germany Italy Portugal Spain
  • Study of ifinatamab deruxtecan alone or in combination with other treatments for patients with metastatic castration-resistant prostate cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    France Germany Ireland Italy The Netherlands Poland +1