Clinical trial · Interventional
Targeted Radiotherapy for Recurrent Prostate Cancer
TArgeted STEreotactic Radiotherapy for Oligorecurrent PROstate Cancer (TASTEPRO) - a Randomized Controlled Pilot Trial
- 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)
The TASTEPRO pilot trial evaluates the feasibility of PSMA PET-CT (Computer tomography) targeted stereotactic radiation therapy (SABR) in management of lymph node positive prostate cancer recurrence after radical prostatectomy. Targeted SABR is compared to current standard; template-based salvage radiation therapy. The investigators expect SABR to be of equal or better oncological outcome compared to the standard therapy with less radiation-induced side-effects. Results of the pilot trial will be used when designing larger trials on oncological efficacy and safety of PSMA PET-CT targeted SABR.
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 |
|---|---|---|---|
| Prostate Cancer Recurrence After Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Current standard template-based salvage therapy | Radiation | — | UNRESOLVED |
| Stereotactic ablative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cohort A - Standard-of-care template-based salvage radiotherapy
- description
- Study participants in cohort A undergo template-based salvage radiotherapy according to current standard-of-care protocol. Dose fractionations include dose of 70/2 Gy in the prostatic bed, 50/2 Gy in the pelvic lymph node area and 45/1,8 Gy in the para-aortic lymph node. To the PSMA PET-CT positive lymph nodes, a boost dose will be considered depending on the anatomic site and will be delivered with a simultaneous integrated boost technique (SIB). The typical boost dose to PSMA PET-CT positive lymph nodes is 57,5/2,3 Gy, respecting normal tissue constraints. The dose to PSMA PET-CT positive areas in the prostatic bed is 74-78/2 Gy.
- interventionNames
- Radiation: Current standard template-based salvage therapy
- type
- EXPERIMENTAL
- label
- Cohort B - PSMA PET CT-targeted stereotactic ablative radiotherapy
- description
- Study participants in cohort B undergo stereotactic ablative radiotherapy, targeted only to PSMA PET-CT-positive areas judged to be suspicious of prostate cancer metastasis by nuclear medicine physician. Dose fractionations in the experimental arm vary from 24/8 Gy to 30/10 Gy in PSMA PET-CT positive lymph nodes in pelvic or para-aortic areas. PSMA PET-CT positive areas in the prostatic bed receive a dose of 35/7 Gy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PSA-relapse, defined as PSA at 0.02 - 1.5 ng/ml after radical prostatectomy * A PSA doubling time of \> 6 months * PSMA PET-CT positivity with a maximum of three lymph node lesions (para-aortic, iliac or obturator nodes) with or without prostate bed involvement * Salvage radiotherapy planned without androgen deprivation treatment Exclusion Criteria: * Chronic inflammatory bowel disease * Bone metastases due to prostate cancer
References
Publications (0)
Data not yet available