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

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

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hospices Civils De Lyon Lyon France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
University Hospital Olomouc Olomouc Czechia
Fundacio Puigvert Barcelona Spain
Umiyhrszak Oq Dwmubiym Debrecen Hungary
Vkytjs dsg Rpyrq Uoxmkhiwok Hxrivplo Sevilla Spain
Utqqhpeffo Huwnvzzf Cxvlohu Cologne Germany
Fjrufqsy nirjniajj Mcqyt a Hdpvdng Prague Czechia
Atuamkwid Hbecrscs Athens Greece
Hlflfphp Untiasigjataq Fsnkkqjsx Jtsneba Ddvs Madrid Spain
Ipvci Ovakbrnu Pfvdjoifufi Sre Mmxikpk Genoa Italy
Uffvrqpgay Ccpnwfzc Hqocpmjr Vihpfd Dn Ll Auuvhauv Murcia Spain
Uxjlggrietfraiemozanx Mundbffd And Munster Germany
Gnfqezqpddqhtoj Ajfygvhvq Antwerp Belgium
Kwyilukp dar Uxbzcnihyovt Mwxvrnuo Auf Munich Germany
Uymqcfvsqcbttvfxqeden Ewucu Afx Essen Germany
Oousyhlcztzcyr Lxkj Gbft Linz Austria
Ugypijsvkxam Zllekrepin Ghkw Gent Belgium
Uhpavmxewtvetcppmrwtd Arwqvx Afl Aachen Germany
Htipcjic Uuapdgdbwdzyx 1w Dg Ohbeucr Madrid Spain
Uwbqhizyjg Dfykm Sfcsj Dh Bjkosvv Brescia Italy
Ugyuudhifdtksvonl Dcjrl Ssqkz Dl Feuhoty Ferrara Italy
Hdwxwnyj Urptjfhksqgvl Vknbpz Dm Lqi Ntstjs Granada Spain
Cwhxpq Hzani Byaizrlkm Rouen France
Owhkibxe Oeyyfrwfzp Ivvbpxz Budapest Hungary
Ttsxzisnlh Cunmjy Hphkmxsq Thessaloniki Greece
Ixsdg Ormgkxdh Spslh Ctumn Dzu Cxwposqr Negrar di Valpolicella Italy
Ugqjyet sqrtg s rhkd Nitra Slovakia
Nxjyovw Otfgzumgwel Ublxh Bratislava Slovakia
Uedwspavbtarhzbdl Dx Pwtk Pisa Italy
Shnxcdawhj Ujjybimitl Budapest Hungary
Nddvvjnwxwd Ckydlx Inptpqlts Amsterdam The Netherlands
Fbqtkfnx Da Rkfgyov Cqtmhl Bslvqadlfyzoboesfv Dfwgpohbttmwnacq Bxxwpspuejk Adfpls Pr I Saieot Barcelona Spain
Vepkhreh Nuyqimzz fykb Gzjcsggrzk Gsjm Berlin Germany
Uwvlhgjibfkoutqdjmjwx Atvltncq Augsburg Germany
Vooujgslhmyywwqg Oyyhyasxpnl Uovpo amvm Kosice Slovakia
Pdudbgyg Uppgpsuwwk Avlvahrlti sifcwh Trencin Slovakia
Iidffigi Cnrze &xhsfip Sibq Stcejnnfafn Saint-Cloud France
Inwwzcwn dh Cgjomxnrhwpr de ljdynotbnfoux Saint-Herblain France
Iouriqbk Cqmak 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)

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