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PubMed · 42389925

Ablative radiotherapy in castration-resistant prostate cancer.

Tobias Hölscher·Fabian Lohaus·Lydia Koi·Jörg Kotzerke·Sebastian Hoberück·Christian Thomas·Angelika Borkowetz·Steffen Löck·Mechthild Krause·Esther G C Troost
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Abstract

OBJECTIVE: To prove the oncological benefit of ablative radiotherapy in patients with up to five metastases from castration-resistant prostate cancer (CRPC) a single-centre randomised trial was initiated. PATIENTS AND METHODS: This monocentric, randomised, phase II clinical trial enrolled patients with up to five prostate-specific membrane antigen-positive bone or lymph node metastases developing prostate-specific antigen (PSA) progression during androgen deprivation (ADT) or ADT and androgen-receptor targeted therapy. Participants were randomised (2:1) to receive metastasis-directed therapy (MDT) or observation (OBS) without changing systemic therapy. The primary endpoint was the proportion of patients having PSA progression within 1 year, with statistical analyses conducted using intention-to-treat principles. Here, results of a planned interim analysis of the primary endpoint are reported. RESULTS: A total of 30 patients (12 in the observation arm and 18 in the MDT arm) were enrolled, PSA progression within 1 year occurred in 44% of the MDT group vs 75% in the OBS group (P = 0.14, not significant). The median time to PSA progression was significantly longer in the MDT arm (12.4 months) compared to the OBS arm (2.9 months, P = 0.03). The pre-defined criteria to discontinue the study were not met. Limitations include the single-centre design and small sample size at interim analysis. CONCLUSION: This pre-planned interim analysis of the primary endpoint did not meet the discontinuation criteria of the study protocol, suggesting that MDT in oligometastatic CRPC may extend the time to PSA progression without immediate change of systemic therapy. The continuation of the study in a multicentre setting is planned (Institutional funding by the TU Dresden, ClinicalTrials.gov identifier: NCT04141709).

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HumansMaleProstatic Neoplasms, Castration-ResistantAgedProstate-Specific AntigenMiddle AgedDisease ProgressionAged, 80 and overAndrogen AntagonistsLymphatic MetastasisBone NeoplasmsTreatment Outcomecastration‐resistant prostate cancermetastasis‐directed therapyoligoprogressionpositron emission tomography/computed tomographyprogression‐directed therapyprogression‐free survivalprostate‐specific membrane antigenrandomised controlled trialstereotactic body radiotherapyJournal ArticleRandomized Controlled TrialClinical Trial, Phase II

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Tobias Hölscher, Fabian Lohaus, Lydia Koi, Jörg Kotzerke, Sebastian Hoberück, Christian Thomas, Angelika Borkowetz, Steffen Löck, Mechthild Krause, Esther G C Troost. 2026-07-02. Ablative radiotherapy in castration-resistant prostate cancer.. https://doi.org/10.1111/bju.70368

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Aged subjectAged, 80 and over subjectBone Neoplasms subjectClinical Trial, Phase II subjectHumans subjectJournal Article subjectJournal Article; Randomized Controlled Trial; Clinical Trial, Phase II resourceMale subjectMiddle Aged subjectRandomized controlled trials studydisease progression subject

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