Table of contents
- Trial overview
- Conditions and patient groups
- Trial phases and study designs
- Outcomes being measured
- What participation means
- Key points for patients
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.[1][2][3]
All three studies are interventional trials, which means researchers assign treatments and then measure the results.[1][2][3]
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.[1][2][3]
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.[1][2][3]
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.[1][3]
Patients in these studies may receive 177LU-PSMA-I&T by intravenous infusion or injection, depending on the trial design.[1][2][3]
Because each trial has a different target group and treatment plan, eligibility depends on the exact study and the cancer features being tested.[1][2][3]
Key points for patients
These trials focus on prostate cancer and other PSMA-positive tumors, so the research is not limited to one setting.[1][2][3]
The studies are trying to learn whether 177LU-PSMA-I&T can improve disease control or delay progression compared with other treatments.[1][2][3]
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.[1][3]
The study goals are different, but they all aim to find better ways to manage advanced prostate cancer or PSMA-positive tumors.[1][2][3]
