In short
Clinical trials are investigating Gozetotide in different cancer settings, mainly as a PET scan tracer used to find PSMA-positive disease. These studies look at how well it helps detect cancer, guide treatment, and predict outcomes in prostate cancer and metastatic renal cancer. Most trials include adults with prostate cancer, and one study includes patients with metastatic clear cell renal carcinoma.
Key points
- Clinical trials investigating Gozetotide are mostly focused on prostate cancer, especially PSMA-positive disease, where the scan may help find cancer more accurately and guide treatment. One study also looks at metastatic clear cell renal carcinoma. The trial phases range from early Phase 1 and Phase 2 studies to larger Phase 3 trials, so the research includes both safety and effectiveness questions. Target groups include men with metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, oligometastatic disease, recurrence after surgery, and some patients with renal cancer. Main outcomes include survival measures, PSA response, disease control, and how well the imaging test detects disease.
Trials overview
Across the trial data, Gozetotide is used in PSMA PET studies, which are imaging studies that look for prostate-specific membrane antigen on cancer cells. Most studies are in prostate cancer, but one trial also includes metastatic clear cell renal carcinoma. The studies are designed to see whether this imaging approach can improve detection, guide treatment, and predict outcomes.
Some studies compare PSMA-based imaging with standard imaging or with other treatment strategies. Others use Gozetotide to help select patients for treatment or to measure how disease changes over time.
Who is being studied
The largest group in these trials is adults with different forms of prostate cancer, including metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, oligometastatic prostate cancer, and biochemical recurrence after surgery. Some trials focus on PSMA-positive disease, which means the cancer shows the target that the scan is designed to find.
One trial includes patients with metastatic clear cell renal carcinoma and studies whether early PSMA PET findings can help predict treatment response. Another study includes patients with progressive PSMA-positive mCRPC and looks at how kidney function may affect the imaging treatment.
- Men with mCRPC are included in several studies because this is a later-stage prostate cancer that has progressed despite hormone control.
- Men with mHSPC are included in trials that test whether PSMA-based imaging or treatment can improve early disease control.
- Patients with recurrence after surgery are studied to see whether PSMA PET can better guide salvage treatment, which means treatment given after cancer returns.
- Patients with oligometastatic disease are included because they have a limited number of metastases, or spread sites, and may benefit from targeted treatment decisions.
Trial phases and study designs
The trial set includes Phase 1, Phase 2, and Phase 3 studies, plus one low-intervention study. Phase 1 studies are early studies that mainly look at safety, tolerability, and dose finding, while Phase 2 studies look more closely at early effectiveness and safety. Phase 3 studies are larger and are usually meant to compare strategies in a more definitive way.
Several studies are randomized, which means participants are assigned by chance to different study groups. Some are open-label, which means both the study team and the participants know which treatment or scan strategy is being used.
Main endpoints being measured
The main endpoints vary by study, but many focus on how long the cancer stays controlled and how well the scan or treatment strategy works. Common endpoints include radiographic progression-free survival, overall survival, PSA response, and disease control rate.
- Radiographic progression-free survival measures the time until scans show the cancer is getting worse or the patient dies.
- Overall survival measures the time until death from any cause.
- PSA response measures whether prostate-specific antigen drops after treatment, often using a 50% decrease or a very low PSA level as the target.
- Disease control rate counts patients with complete response, partial response, or stable disease, and may count non-evaluable patients as non-responders in some studies.
- Safety and tolerability endpoints track side effects, lab changes, vital signs, ECGs, dose interruptions, reductions, and treatment stopping.
Key trials using Gozetotide
In the ISEE-RCC study, Gozetotide is used in metastatic clear cell renal carcinoma to compare tumor detection on PSMA PET-CT with another PET method and standard contrast CT. The goal is to see whether Gozetotide can help identify tumors more clearly in patients with suspected metastatic disease.
In the PSMA-SELECT study, PSMA PET/CT is being evaluated as a tool to help decide whether patients need extended pelvic lymph node dissection, which is surgery to remove lymph nodes in the pelvis. The study also looks at biochemical recurrence within two years after surgery, which means the PSA rises again after treatment.
In the P4RTY trial, PSMA PET is used before radiotherapy in intermediate- or high-risk prostate cancer to see whether imaging based treatment planning improves progression-free survival. This trial compares PSMA PET-based care with standard-of-care imaging.
In PSMAfore, men with taxane-naïve progressive PSMA-positive mCRPC are studied to see whether 177Lu-PSMA-617 improves radiographic progression-free survival compared with a change of androgen receptor-directed therapy. Although this trial focuses on treatment, Gozetotide is part of the imaging selection process.
In the ReaLuP study, patients with mCRPC who previously received a first course of [177Lu]Lu-PSMA are re-treated to see whether radiological progression-free survival at 24 weeks can be improved. Gozetotide is used to support PSMA-based selection in this setting.
In NCT06004661, the study looks at dosimetry, safety, and tolerability in patients with impaired or normal kidney function, with special attention to absorbed radiation dose in the kidney and other organs. This is important because it helps show whether kidney function changes how the study procedure behaves in the body.
What the trials aim to learn
Overall, these trials are trying to learn whether Gozetotide-based PSMA imaging can better find cancer, help choose the right treatment, and predict who is more likely to benefit from therapy. They also aim to show whether this approach can improve major outcomes such as progression-free survival, disease control, and survival in selected patient groups.
Some studies focus on practical questions, such as whether PSMA PET can reduce unnecessary surgery, lower treatment burden, or improve cost-effectiveness. Others focus on whether early changes on the scan can match later treatment results, which could help doctors make decisions sooner.