Study on Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan for Adults with Prostate Cancer

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment for prostate cancer. The treatment being investigated is called lutetium (177Lu) vipivotide tetraxetan, also known by its code name AAA617. This medication is given as a solution for injection or infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to gather more information about the long-term effects of this treatment, especially any known or potential risks.

Participants in this study will be monitored for up to 10 years after receiving their first dose of the treatment. The study aims to observe any side effects, such as myelosuppression (a condition where bone marrow activity is decreased, leading to fewer blood cells), renal failure (a condition where the kidneys stop working properly), xerostomia (dry mouth), xerophthalmia (dry eyes), and the development of other serious conditions like myelodysplastic syndrome and acute myeloid leukemia. The study will also look for any other serious adverse reactions that may occur.

Throughout the study, researchers will collect data on the incidence and proportion of participants experiencing these side effects, as well as any changes in laboratory values. The study will also track the incidence and proportion of deaths among participants. This information will help to better understand the long-term safety of lutetium (177Lu) vipivotide tetraxetan in treating prostate cancer.

1 joining the study

Participation begins after receiving at least one dose of AAA617 in a previous clinical trial for prostate cancer.

Eligibility is confirmed based on prior trial requirements.

2 treatment administration

The medication used is Pluvicto, a solution for injection or infusion.

The active substance is lutetium (177Lu) vipivotide tetraxetan.

Administration is done intravenously, meaning it is injected directly into a vein.

3 monitoring and follow-up

The study aims to monitor long-term safety for up to 10 years after the first dose.

Focus is on identifying known or potential risks such as myelosuppression (a decrease in bone marrow activity), renal failure, dry mouth, dry eyes, and secondary cancers like myelodysplastic syndrome and acute myeloid leukemia.

Other serious adverse reactions are also monitored.

4 data collection

The primary goal is to record the incidence and proportion of participants experiencing selected adverse events and serious adverse events.

Changes in laboratory values are also tracked.

5 study duration

The study is expected to continue until July 7, 2033.

Recruitment for the study began on October 23, 2023.

Who Can Join the Study?

  • The patient must be male.
  • The patient must have prostate cancer.
  • The patient must have received at least one dose of a treatment called AAA617 in a previous clinical trial sponsored by Novartis for prostate cancer.
  • The patient must have completed all the requirements of the previous trial to be eligible for this study.
  • The patient must be within the specified age range for the study.

Who Cannot Join the Study?

  • Only male patients can participate. Female patients are not eligible.
  • Patients with conditions that make them vulnerable 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
Institut Gustave Roussy Villejuif France
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Rostock University Medical Center Rostock Germany
University Hospital Maastricht Maastricht The Netherlands
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Reinier de Graaf Groep Delft The Netherlands
University Hospital Olomouc Olomouc Czechia
Hospital General Universitario Gregorio Maranon Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Institut Jules Bordet Anderlecht Belgium
Virgen del Rocío University Hospital Sevilla Spain
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Centre Hospitalier Regional Universitaire De Nancy Nancy France
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Universitair Ziekenhuis Gent Gent Belgium
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Plpb Tgyxa Hljkdsgc Upjmnbclcpay Sabadell Spain
Smebdbpkj Rutjccx Ukeokgpaqa Mvonecf Ccmuaf Nijmegen The Netherlands
Uttxywpzwu Hwhjqlcy Czuhzxb Cologne Germany
Fyvsebzu nqjrqkken Mwfns a Hjbqssn Prague Czechia
Sdrbqgokovf Uxxhxsfqxs Halzrmpphlgknax Gklopmjvbzlwuavxq Gothenburg Sweden
Htqgtxyw Dt Lk Sloeh Cxso I Sstg Pwe Barcelona Spain
Chwhza Lfdp Bjoees Lyon France
Uszcvdtzglkymffgmoiuk Efnfo Aby Essen Germany
Onncxwsgnkhtkn Lbhm Gddn Linz Austria
Igoyqehi Cptnuq Dcnebklgnlqknbwek L'hospitalet De Llobregat Spain
Fgfysuspw Pxyy Lw Idvqkdmrspprz Booaiwczf Dmb Hvktknvq Ufyrpsvfwrtlh Lf Pgd Madrid Spain
Hlhznebv Vrbq dhynwaqa Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
23.10.2023
Belgium Belgium
Recruiting
23.10.2023
Czechia Czechia
Not yet recruiting
23.10.2023
France France
Recruiting
23.10.2023
Germany Germany
Recruiting
23.10.2023
Italy Italy
Not yet recruiting
23.10.2023
Poland Poland
Not yet recruiting
23.10.2023
Spain Spain
Recruiting
23.10.2023
Sweden Sweden
Recruiting
23.10.2023
The Netherlands The Netherlands
Recruiting
23.10.2023

Trial locations

AAA617 is a medication being studied for its long-term safety in adults with prostate cancer. It is used to treat prostate cancer by delivering targeted radiation therapy. The study aims to monitor any known or potential risks associated with this treatment, such as effects on blood cell production, kidney function, dry mouth, dry eyes, and the development of other cancers.

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulties with urination, blood in the urine, or pelvic discomfort. In some cases, it may spread to other parts of the body, such as the bones or lymph nodes. The progression can vary greatly among individuals, with some experiencing rapid advancement and others having a more indolent course.

Trial ID:
2023-503208-94-00
Protocol code:
CAAA617A12402
NCT ID:
NCT05803941
Trial Phase:
Therapeutic confirmatory (Phase III)

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