Clinical trial · Observational
STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence After prostatectomy-a Prospective Observational Study
STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence After prostatectomy-a Prospective Observational Study -STARR
NCT05455736CI-TRIAL-00059648STARRunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
STereotactic sAlvage Radiotherapy for macroscopic prostate bed Recurrence after prostatectomy (STARR trial) is a prospective observational study aimed to assess outcome after Stereotactic salvage radiotherapy (SSRT) for macroscopic prostate bed recurrence after radical prostatectomy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic salvage radiotherapy for macroscopic prostate bed relapse | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Biochemical relapse free survival (BRFS)
- timeFrame
- 2 year
- description
- Primary endpoint of the study is BRFS after treatment, biochemical relapse is defined as a PSA increase above 0.2 ng/ml for patients with a PSA nadir \< 0.2 ng/ml or 2 consecutive PSA increases \> 25% if compared to nadir in patients with a PSA nadir \> 0.2 ng/ml.
Secondary outcomes (1)
- measure
- Rate of patients with complete response
- timeFrame
- at 2 years after treatment
- description
- Complete response is defined as PSA nadir \<0.2 ng/ml
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients affected by biochemical recurrence after radical prostatectomy for prostate cancer (defined as a PSA increase \> 0.2 ng/ml) * Presence of macroscopic recurrence in prostate bed, determined with either Choline or PSMA PET imaging and confirmed through MRI (except for cases in which MRI is contraindicated) * Absence of distant and/or regional sites of disease outside prostate bed * Patients free from Androgen deprivation therapy (ADT) (Adjuvant ADT after radical prostatectomy for pN+ patients is allowed if \> 12 months from biochemical recurrence) Exclusion Criteria: * Presence of distant and/or regional sites of disease outside prostate bed * Patient undergoing ADT or withdrawal of adjuvant ADT within12 months from biochemical recurrence * Absence of disease detection from one of the two imaging modalities used (Choline or PSMA Pet and MRI must be positive- except for cases in which MRI is contraindicated) * Any condition for which, in the opinion of the treating physician, SSRT would be contraindicated for the patient (i.e peristence of moderate/severe urinary distress after prostatectomy, post-surgical complications etc)
References
Publications (0)
Data not yet available
No reference posted for this study.