A Study of Adjuvant Treatment with Lutetium (177Lu) Vipivotide Tetraxetan in Patients with Oligometastatic Prostate Cancer

Prostate cancer is a common form of cancer in men that originates in the prostate gland. If the tumor recurs after initial treatment (e.g., surgery or radiation therapy), it sometimes appears in the form of small secondary tumors (metastases). These early metastases can often be treated in a targeted manner to control the disease. Typically, anti-hormonal therapy (androgen deprivation therapy, ADT) would be initiated in this situation to lower testosterone levels, but it is often associated with side effects such as fatigue, loss of libido, and muscle wasting.

The goal of this Phase 3 study is to investigate whether a targeted, PSMA-based radioligand—lutetium (177Lu) vipivotide tetraxetan—can delay the need for such antihormonal therapy. The drug binds to a specific protein (PSMA) on the surface of prostate cancer cells and releases radioactive radiation there in a targeted manner to destroy the cancer cells, while largely sparing healthy tissue. All study participants will first receive targeted radiation therapy to the existing metastases (Stereotactic Body Radiation Therapy, SBRT). They will then be randomly assigned to one of two groups: The first group will also receive lutetium (177Lu) vipivotide tetraxetan, administered every 6 weeks—for a total of up to 4 cycles. The second group will simply be monitored after radiation therapy (“watchful waiting”). The study will assess whether the time until the recurrence of additional metastases or until the need for anti-hormone therapy is prolonged. Additional objectives include quality of life, disease progression (e.g., PSA increase, radiological findings), and treatment tolerability.

Eligible participants are men aged 18 and older with prostate cancer who, following successful initial therapy, have a maximum of five PSMA-positive metastases outside the prostate (without involvement of the liver or brain)—that is, so-called oligometastatic prostate cancer. Currently, there must be no need for anti-hormone therapy, nor should such therapy have already been administered, and testosterone levels must be within the normal range. Men with newly diagnosed metastatic disease (i.e., no prior treatment) are excluded.