Clinical trial · Interventional
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP
Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study
- 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)
After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients. The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| salvage SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- single arm, non randomized
- description
- SBRT 30 Gy/ 5 fractions
- interventionNames
- Radiation: salvage SBRT
- type
- EXPERIMENTAL
- label
- radiation, SBRT
- description
- SBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes
- interventionNames
- Radiation: salvage SBRT
Primary outcomes (1)
- measure
- 3-yr BFFS
- timeFrame
- 3-years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- Able and willing to provide informed consent; * Pathologically proven diagnosis of prostatic adenocarcinoma; * Biochemical failure (2 consecutive PSA rises above 0.2 ng/ml) after radical prostatectomy; * No regional or distant metastases; * Eastern Cooperative Oncology Group performance status 0-1 Exclusion Criteria: * \- Previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy; * Previous radiotherapy to the pelvis; * Previous or current symptomatic vesicourethral anastomotic stenosis post-RP (weak stream, straining to void, hesitancy and incomplete bladder emptying); * PSA level at sRT\> 2 ng/ml; * (Each single) Lesion volume within the prostatic fossa at mpMR \>5 cc; * Previous chemotherapy for malignancy in past 5 years; * Previous androgen deprivation for biochemical failure after RP; * Contraindication to short term AD (in case of Px) * Presence of nodal or distant metastasis, as confirmed by magnetic resonance (MR) or PET/CT * Pathologically positive lymph nodes (pN+) at RP; * Serious medical comorbidities or other contraindications to radiotherapy * Presence of active inflammatory bowel disease; * Presence of active connective tissue disease; * Unable or unwilling to complete quality of life questionnaires
References
Publications (0)
Data not yet available