In short
Clinical trials are studying 177LU-PSMA-I&T in prostate cancer and other PSMA PET/CT positive advanced or metastatic tumors. These studies look at how well it works, how safe it is, and which patients may benefit most. The trials include men with hormone-sensitive prostate cancer and patients with different tumor types.
Key points
- Clinical trials of 177LU-PSMA-I&T are studying prostate cancer and other PSMA PET/CT positive advanced or metastatic tumors. The listed studies include Phase 2 and Phase 3 research, so they are testing both early effectiveness and larger comparisons between treatments. One trial focuses on men with oligometastatic hormone-sensitive prostate cancer, another looks at a basket of different tumor types, and a third studies metastatic hormone-sensitive prostate cancer. The main outcomes include progression-free survival, PSA progression-free survival, disease control rate, and safety. Planned enrollment ranges from small to large groups, from 70 to 844 participants. Together, these trials aim to show whether 177LU-PSMA-I&T can help control disease better than the comparison treatments.
Trial overview
The available clinical trials are studying 177LU-PSMA-I&T in prostate cancer and in PSMA PET/CT positive advanced or metastatic tumors.123
All three studies are interventional trials, which means researchers assign treatments and then measure the results.123
Conditions and patient groups
One Phase 2 trial is for men with oligometastatic hormone sensitive prostate cancer, which means the cancer has spread to only a small number of places and still responds to hormone treatment.1
Another Phase 2 trial includes patients with PSMA PET/CT positive advanced/metastatic tumours, so it is not limited to only one cancer type.2
The Phase 3 study is for people with metastatic hormone sensitive prostate cancer who are PSMA positive, and it compares 177LU-PSMA-I&T with standard hormone-based treatment options.3
Trial phases and study designs
The listed trials are in Phase 2 and Phase 3.123
Phase 2 trials usually look at early signs of benefit and continue to check safety, while Phase 3 trials compare treatments in larger groups to see which approach works better.123
The LUST study compares Lu-PSMA and Stereotactic Radiotherapy versus radiotherapy alone for oligometastatic prostate cancer.1
The LUBASKET study is a basket trial, which means it brings together different tumor types under one research plan.2
The Phase 3 study compares 177LU-PSMA-I&T with Apalutamide, Enzalutamide, or Abiraterone Acetate in a randomized design, meaning participants are assigned by chance to one treatment arm or another.3
Outcomes being measured
The LUST trial’s main outcome is the proportion of men who have PSA progressed after 12 months, which is reported as 12-month PSA-progression-free survival.1
The LUBASKET trial measures disease control rate, which includes complete response, partial response, stable disease, or no progression of disease for prostate cancer by trial rules.2
The same basket trial also measures safety, including acute toxicity from the first treatment until 30 days after the last treatment cycle.2
The Phase 3 study measures progression-free survival, including radiographic, clinical, or PSA progression-free survival, and uses PCWG3 and RECIST 1.1 rules to define progression.3
What participation means
Across these studies, planned enrollment ranges from 70 people in the LUST trial to 844 people in the Phase 3 comparison trial.13
Patients in these studies may receive 177LU-PSMA-I&T by intravenous infusion or injection, depending on the trial design.123
Because each trial has a different target group and treatment plan, eligibility depends on the exact study and the cancer features being tested.123
Key points for patients
- These trials focus on prostate cancer and other PSMA-positive tumors, so the research is not limited to one setting.123
- The studies are trying to learn whether 177LU-PSMA-I&T can improve disease control or delay progression compared with other treatments.123
- The trials also track safety, which means they watch for unwanted effects during and shortly after treatment.2
- Some trials compare 177LU-PSMA-I&T with radiotherapy alone or with standard hormone-based medicines.13
- The study goals are different, but they all aim to find better ways to manage advanced prostate cancer or PSMA-positive tumors.123