SPRINTR-Trial-1 is a platform study with the aim to continue for 20 years to increasingly evaluate novel treatments and biomarker selection for prostate cancer patients with the dual  goal to reduce prostate cancer mortality, balanced by sustained Quality of Life by de-escalation in selected patients   

SPRINTR-Real and SRPINTR-Trial integration:

• Biomarker profiling phase within SPRINTR-Real
  Integrates standard-of-care diagnostics with extended molecular analyses to identify actionable targets.

• Treatment phase (Included in SPRINT-TRIAL)
  "Doctor´s choice" (together with the patient's choice) decides curative intention strategy between Surgery or Radiotherapy. Patients are allocated to treatment strategies using non-biomarker-driven and biomarker-driven randomization in the neoadjuvant and adjuvant settings, respectively.

Study Population

The trial includes adult patients (≥18 years) with:

• Unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer

• Planned curative treatment (radical prostatectomy or radiotherapy)

• Good performance status (ECOG 0–1) and adequate organ function

Treatment Strategy

SPRINTR evaluates biomarker-guided treatment escalation and de-escalation:

• Patients receive standard-of-care therapy and/or targeted treatment depending on molecular profile.

• Randomization is applied where appropriate between different SoC based on present guidelines versus experimental arms (e.g., escalation or de-escalation therapies).

• Platform flexibility allows the incorporation of new therapeutic strategies as they become clinically relevant.
  

Primary and secondary end points

The primary endpoint is metastasis-free survival, complemented by key secondary outcomes including survival, disease progression, treatment response, and quality of life.

Analysis for the exalation arm is to detect superiority and in the analysis for de-escalation the analysis will be based on non-inferiority