What question did this study set out to answer?

This trial aims to assess the safety and efficacy of image-guided, tumor-focused radiotherapy compared to standard whole-gland radiotherapy in patients with intermediate- or high-risk prostate cancer.

May 18, 2026Open Access

Trial protocol: RadTARGET, a multicenter phase II randomized controlled trial evaluating focal radiotherapy boost with de-intensification of dose to non-suspicious prostate in patients with intermediate- or high-risk prostate cancer

Key Points

This trial aims to assess the safety and efficacy of image-guided, tumor-focused radiotherapy compared to standard whole-gland radiotherapy in patients with intermediate- or high-risk prostate cancer.
Multicenter phase II trial with randomization into standard RT and tumor-focused RT arms.
Target population includes patients with intermediate- or high-risk prostate cancer undergoing definitive RT.
Primary endpoint is the comparison of acute genitourinary or gastrointestinal grade ≥2 adverse events between the two treatment arms.
Safety profile of tumor-focused RT is hypothesized to be superior, with a potential reduction in adverse events.
Efficacy will be assessed based on acute GI or GU adverse events.
Development of a phase III trial is considered if non-inferiority of tumor-focused RT is confirmed.

Abstract

Abstract Definitive radiotherapy (RT) for prostate cancer (PC) with dose intensification and/or focal boosting has excellent oncologic outcomes, but many patients experience adverse events. Dose escalation to the whole prostate improves outcomes at the expense of increased late adverse events. Intraprostatic recurrence after definitive RT typically occurs at the site of the primary tumor, suggesting that dose to the site of the dominant lesion is an important predictor of future failure. The efficacy and safety of tumor-focused RT compared to that of standard RT for definitive treatment of localized PC has not been assessed. RadTARGET (RAdiation Dose TAiloRing Guided by Enhanced Targeting; NCT06990542) is a phase II randomized trial that aims to demonstrate superior safety of image-guided, tumor-focused RT compared to standard RT for acute genitourinary (GU) or gastrointestinal (GI) in the setting of definitive RT for intermediate- and high-risk PC. The study intervention is image-guided, tumor-focused RT with dose intensification of cancer visible on imaging and dose de-intensification to remaining prostate. Patients will be randomized to two arms: those who receive standard RT dose and those that receive tumor-focused RT. The study population will be patients with intermediate- or high-risk PC planning to undergo definitive RT with or without systemic therapy. The primary endpoint to compare between randomized arms is acute GU or GI grade ≥2 adverse events. Participant and study duration are 5 years and 8 years, respectively. RadTARGET will compare the efficacy and safety of tumor-focused RT to that of standard RT for definitive treatment of localized PC. We hypothesize that the tumor-focused approach will substantially reduce adverse events after prostate RT while retaining high efficacy. If this hypothesis is confirmed, we will conclude that a phase III randomized control trial is warranted to formally establish oncologic non-inferiority compared to the current standard of whole-gland dose escalation.

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