Table of contents
- Trials overview
- Who is being studied
- Trial phases and study designs
- Main endpoints being measured
- Key trials using Gozetotide
- What the trials aim to learn
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.[1] Most studies are in prostate cancer, but one trial also includes metastatic clear cell renal carcinoma.[2] The studies are designed to see whether this imaging approach can improve detection, guide treatment, and predict outcomes.[3]
Some studies compare PSMA-based imaging with standard imaging or with other treatment strategies.[4] Others use Gozetotide to help select patients for treatment or to measure how disease changes over time.[5]
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.[6] Some trials focus on PSMA-positive disease, which means the cancer shows the target that the scan is designed to find.[7]
One trial includes patients with metastatic clear cell renal carcinoma and studies whether early PSMA PET findings can help predict treatment response.[2] Another study includes patients with progressive PSMA-positive mCRPC and looks at how kidney function may affect the imaging treatment.[8]
- Men with mCRPC are included in several studies because this is a later-stage prostate cancer that has progressed despite hormone control.[6]
- Men with mHSPC are included in trials that test whether PSMA-based imaging or treatment can improve early disease control.[9]
- Patients with recurrence after surgery are studied to see whether PSMA PET can better guide salvage treatment, which means treatment given after cancer returns.[10]
- Patients with oligometastatic disease are included because they have a limited number of metastases, or spread sites, and may benefit from targeted treatment decisions.[11]
Trial phases and study designs
The trial set includes Phase 1, Phase 2, and Phase 3 studies, plus one low-intervention study.[12] 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.[13] Phase 3 studies are larger and are usually meant to compare strategies in a more definitive way.[14]
Several studies are randomized, which means participants are assigned by chance to different study groups.[6] Some are open-label, which means both the study team and the participants know which treatment or scan strategy is being used.[6]
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.[7] Common endpoints include radiographic progression-free survival, overall survival, PSA response, and disease control rate.[7]
- Radiographic progression-free survival measures the time until scans show the cancer is getting worse or the patient dies.[7]
- Overall survival measures the time until death from any cause.[15]
- PSA response measures whether prostate-specific antigen drops after treatment, often using a 50% decrease or a very low PSA level as the target.[6]
- 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.[2]
- Safety and tolerability endpoints track side effects, lab changes, vital signs, ECGs, dose interruptions, reductions, and treatment stopping.[8]
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.[2] The goal is to see whether Gozetotide can help identify tumors more clearly in patients with suspected metastatic disease.[2]
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.[1] The study also looks at biochemical recurrence within two years after surgery, which means the PSA rises again after treatment.[1]
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.[4] This trial compares PSMA PET-based care with standard-of-care imaging.[4]
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.[7] Although this trial focuses on treatment, Gozetotide is part of the imaging selection process.[7]
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.[16] Gozetotide is used to support PSMA-based selection in this setting.[16]
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.[8] This is important because it helps show whether kidney function changes how the study procedure behaves in the body.[8]
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.[3] 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.[7]
Some studies focus on practical questions, such as whether PSMA PET can reduce unnecessary surgery, lower treatment burden, or improve cost-effectiveness.[4] Others focus on whether early changes on the scan can match later treatment results, which could help doctors make decisions sooner.[2]
