Clinical trial · Interventional
Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer
A Randomized Trial Comparing Conventional "Salvage" Radiotherapy and Individualized 68Ga-PSMA-11 or 18F-PSMA-1007 PET/CT Targeted Treatment in Patients With Biochemical Recurrence After Prostate Cancer Surgery
- 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)
Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT. Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact. In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualised therapy | Combination Product | — | UNRESOLVED |
| Standard salvage therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Individualised therapy based on results of the PSMA PET/CT.
- interventionNames
- Combination Product: Individualised therapy
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- Standard salvage therapy. Results of PSMA PET/CT blinded.
- interventionNames
- Radiation: Standard salvage therapy
Primary outcomes (1)
- measure
- Primary PSA progression free survival
- timeFrame
- Throughout the study, approximately 10 years.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA \>0.2 \<2.0 ng/mL, and increasing measured twice. * Multidisciplinary conference (MDK) decision to offer the patient SRT * Signed Informed Consent Exclusion Criteria: * Patients previously treated for prostate cancer with biochemical recurrence * Previous treatment with androgen deprivation therapy (ADT) after surgery * Previous pelvic radiotherapy * Patients with positive lymph nodes at surgery
References
Publications (0)
Data not yet available