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A study to evaluate the effects of lutetium (177lu) vipivotide tetraxetan in patients with metastatic hormone sensitive prostate cancer receiving androgen deprivation therapy.

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What is this study about?

This study focuses on individuals with Metastatic hormone sensitive prostate cancer, a type of prostate cancer that has spread to other parts of the body and is still responsive to hormone treatments. Participants in the study are currently receiving androgen deprivation therapy, which is a method used to lower the levels of male hormones to help slow the growth of cancer cells. The purpose of the study is to determine if adding new treatments to the standard care can improve survival and cancer outcomes.

One of the treatments being tested is lutetium (177lu) vipivotide tetraxetan, which is administered as a solution for injection or infusion directly into a vein. This medication is a type of radiopharmaceutical, meaning it contains a small amount of radiation designed to target cancer cells. The study follows a specific design to compare different treatment approaches against standard care to see which options are most effective for patients.

Who Can Join the Study?

  • You must be at least 18 years old.
  • You must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of cancer that starts in the prostate gland.
  • Medical imaging, such as a CT scan, MRI, or PET scan, must confirm that the cancer has spread to other parts of the body.
  • The cancer must have spread to at least one of the following areas: the bones, lymph nodes (small glands in the immune system), or visceral organs (internal organs like the liver or lungs).
  • If the cancer is only in the lymph nodes, at least one node must be at least 1.5cm in size and located outside of the pelvis area.
  • Your cancer must either be newly diagnosed or have returned after previous treatment.
  • If the cancer has returned, it must still be hormone sensitive, meaning the cancer cells still grow in response to hormones.
  • If the cancer has returned, you must have finished all hormone treatments, such as ADT (androgen deprivation therapy, which lowers hormone levels to slow cancer growth) or ARPI (a type of hormone therapy), at least 2 years ago.
  • You must have received a total of 3 years or less of ADT at the time you are assigned to a study group.
  • You must have started, or plan to start, long-term androgen deprivation therapy for at least 2 years.
  • Your WHO Performance Status, which is a scale used by doctors to measure how well you can perform daily activities, must be between 0 and 2. A score of 3 may be acceptable if it is caused by the cancer and is expected to improve with hormone therapy.
  • You must be willing and able to follow the treatments required for the study.
  • You must sign an informed consent form, which is a document you sign to show you understand the study and agree to participate.

Who Cannot Join the Study?

  • You have small cell carcinoma, which is a specific, aggressive type of cancer that is clearly visible through medical exams or tissue samples.
  • You have cancer that has spread to your brain or to the leptomeninges, which are the protective layers of tissue that surround your brain and spinal cord.
  • You have any other active cancers that are growing or required treatment in the last 36 months, excluding certain types of bladder, skin, or cured cancers.
  • You have any other medical condition that the doctor believes makes it unsafe or unsuitable for you to receive long-term androgen deprivation therapy (a treatment that lowers hormone levels to slow cancer growth) or the study medicines.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Jena KöR Jena Germany
Hospital Universitario De Salamanca Salamanca Spain
Technische Universitaet Dresden Dresden Germany
Hospital Universitario Hm Sanchinarro Madrid Spain
Rostock University Medical Center Rostock Germany
Universitätsklinikum Freiburg Freiburg Im Breisgau Germany

Other Sites

Site Name City Country Status
Hospital Del Mar Barcelona Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
UPMC Hillman Cancer Centre, UPMC Whitfield Hospital Waterford Ireland
Bnlaedzb Hckowcuy Dublin Ireland
Udgvawsdwwbuvggjynvwn Tmczuriuz Adu Tuebingen Germany
Hgrslhjb Cooukb De Bdmwdeawa Barcelona Spain
Uzpccymzwc Cbkixhok Hdivjbpm Vhwzxk Dd Lv Axplunxd Murcia Spain
Usipqvdtwytf Dr Szwoxvyh Dg Cnfjgxqesw Santiago De Compostela Spain
Hbfgaoad Cymvkwd Sip Cqquym Madrid Spain
Hrqncsgm Df Lg Sgtlz Chzy I Sgbm Ptq Barcelona Spain
Sx Vecfcqwiqpjfqce Unzecymiyg Hfczmcwt Dublin Ireland
Ksxwzvus dis Tcysqaeotgm Ujdhgrpfywgg Mgqcrmbu (ter Kjtpcfovd Munich Germany
Ujhiykevrciqedlctlcnk Egaoy Aus Essen Germany
Iktwklwh fgjx Kiwjelgsi Tewfruwipryxpldxlhp uvb Ipetccmstmzr Unp ghqns Ulm Germany
Hmoalpjx Uwfrinbuwcizh 1d Dh Oyfvygv Madrid Spain
Iulurabb Cgrfpd Ddljokbcusrcicuaq L'hospitalet De Llobregat Spain
Fdmjadawl Peoa Lv Itdfdypzbqrmo Bkqbdctfa Dba Hspjqksg Ubtjhkljlhxan La Pvt Madrid Spain
Fpyijbvgv Imlysoflv Vffsshoqyg Dx Ogmskfhsp Valencia Spain
Htyauqbv Uhsatwwqopfeu Vojxhi Dm Ld Vhtzcxvr Malaga Spain
Soqkx Lnsyvehacupx Rabaqyojw Ohhapbvw Nxnaznc Dublin Ireland
Ldaand Mbtqoyvvem Unillsylav Ol Midlzg Munich Germany
Hjtykjal Uvrmevelrcnxf Dbzdroqb Donostia / San Sebastian Spain
Cwhm Ucafjqrncj Hhzrozjm Cork Ireland
Sfvhb Lrkplfvtkapi Ryazyfxqv Ookhcpqf Ngibupt Dublin Ireland

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

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
15.12.2025
Ireland Ireland
Not yet recruiting
15.12.2025
Spain Spain
Recruiting
15.12.2025

Trial locations

Investigated Drugs:

Pluvicto is a treatment given through a vein that uses a special radioactive substance designed to find and target certain cells in the body to help fight prostate cancer.

Investigated Diseases:

Metastatic hormone sensitive prostate cancer – This is a type of cancer that begins in the prostate gland and has spread to other parts of the body. The cancer cells are initially responsive to hormone therapy, which works by lowering the levels of hormones that help the cancer grow. As the disease progresses, the cancer cells move beyond the prostate to locations such as the bones or lymph nodes. It is characterized by the presence of cancer in distant organs or tissues while still being influenced by androgen hormones.

Trial ID:
2025-522145-21-00
Protocol code:
PR12
NCT ID:
NCT06320067
Trial Phase:
Therapeutic confirmatory (Phase III)

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