---
title: "Early 68Ga-PSMA-11 PET/CT to Predict 6-Month Disease Control in Metastatic ccRCC: PSMA-RENAL Phase"
id: "bmj-open-18-can-early-68ga-psma-11-pet-ct-predict-6-month-disease-control-in-patients"
canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-18-can-early-68ga-psma-11-pet-ct-predict-6-month-disease-control-in-patients"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "BMJ Open"
source_url: "http://bmjopen.bmj.com/cgi/content/short/16/9/e119297?rss=1"
published_at: "2026-09-18T12:04:54.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Early 68Ga-PSMA-11 PET/CT to Predict 6-Month Disease Control in Metastatic ccRCC: PSMA-RENAL Phase
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-18-can-early-68ga-psma-11-pet-ct-predict-6-month-disease-control-in-patients
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** BMJ Open
- **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/9/e119297?rss=1)
- **Published At:** 2026-09-18T12:04:54.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The PSMA-RENAL study is a prospective, multicentre, phase II trial evaluating whether early changes on **68Ga-PSMA-11 PET/CT** predict 6-month disease control in patients with metastatic **clear cell renal cell carcinoma (ccRCC)** receiving first-line immune checkpoint inhibitor (ICI)-based systemic therapy. - Rationale: conventional imaging struggles with pseudo-progression, mixed or delayed responses; **PSMA** is expressed in ccRCC neovasculature, making PSMA-targeted PET a potential early biomarker of treatment efficacy. - Key procedures: baseline and week-6 **68Ga-PSMA-11 PET/CT** for enrolled patients with histologically confirmed metastatic ccRCC and PSMA-positive lesions; conventional CT or MRI with bone scan every 12 weeks. - Primary outcome: the association between percentage change in SUVmax on 68Ga-PSMA-11 PET/CT from baseline to week 6 and disease control rate (DCR) at 6 months, where DCR = complete response, partial response, or stable disease on conventional imaging. - Secondary outcomes: associations between early PSMA-PET change and objective response rate; baseline PSMA uptake and DCR; early PSMA-PET change and progression-free survival. - Sample size and power: planned recruitment of 75 patients (accounting for 10% drop-out), assuming 90% PSMA-positivity; the study has 80% power to detect a clinically meaningful difference in the AUC of the ROC curve. - Ethics and registration: ethics approval obtained, written informed consent required; trial registered with EU reference CTIS: 2024-517098-26-00 (Protocol code: PSMA-RENAL); date of registration March 2025. The study is currently recruiting. - Clinical implication: first study to test whether early PSMA-PET changes can identify responders to systemic therapy in metastatic ccRCC, potentially supporting earlier therapeutic adjustments and improved resource allocation.
## Clinical Analysis & Structured Key Points
Introduction The introduction of immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors has improved outcomes in metastatic clear cell renal cell carcinoma (ccRCC). However, conventional imaging modalities often lack efficacy for response evaluation, facing challenges such as pseudo-progression, mixed responses or delayed responses. Prostate-specific membrane antigen (PSMA) is expressed in the neovasculature of ccRCC, suggesting that PSMA-targeted positron emission tomography (PET) imaging may serve as an early biomarker of treatment efficacy. Methods PSMA-RENAL is a prospective, multicentre, phase II trial enrolling patients with histologically confirmed metastatic ccRCC and PSMA-positive lesions. Patients will undergo 68 Ga-PSMA-11 PET/CT imaging at baseline and 6 weeks after initiation of ICI-based systemic therapy. Conventional imaging (CT or MRI with bone scan) will continue every 12 weeks. The primary outcome is the association between the percentage change in Standardized Uptake Value (SUV)max on ⁶⁸Ga-PSMA-11 PET/CT from baseline to week 6 and disease control rate (DCR) at 6 months. Disease control is defined as complete response, partial response or stable disease on conventional imaging. Secondary outcomes are the association between early change in PSMA-PET uptake and objective response rate, the association between baseline PSMA-PET uptake and DCR, and the association between early change in PSMA-PET uptake and progression-free survival. A total of 75 patients will be recruited, accounting for a 10% drop-out rate and assuming a 90% PSMA-positivity rate. The study has 80% power to detect a clinically meaningful difference in the area under the receiver operating characteristic curve. Analysis This study is the first to evaluate whether early changes in PSMA-PET imaging can predict outcomes in patients with metastatic ccRCC receiving systemic therapy. Early identification of responders may allow timely therapeutic adjustments, potentially enhancing patient outcomes and optimising healthcare resource allocation. Ethics and dissemination The protocol has received ethical approval. All participants will provide written informed consent. Trial registration number Trial Registration: EU reference number (CTIS): 2024-517098-26-00. Protocol code: PSMA-RENAL. Trial Phase: Therapeutic exploratory (Phase II). Date of registration: March 2025. Currently recruiting.
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