Clinical trial · Interventional
Tracer-Guided Surgery for Recurrent Prostate Cancer
Tracer-Based Image Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial
NCT05555017CI-TRIAL-00070245Trace-IIunknownPhase 2ClinicalTrials.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)
ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.
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 |
|---|---|---|---|
| ADT | Drug | — | UNRESOLVED |
| PSMA-radioguided surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: ADT
- description
- Patients in arm A will receive standard 6 months of ADT according to current clinical guidelines.
- interventionNames
- Drug: ADT
- type
- EXPERIMENTAL
- label
- Arm B: ADT + PSMA radioguided surgery
- description
- Patients in arm B will receive standard 6 months of ADT according to current clinical guidelines, and will undergo 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery.
- interventionNames
- Procedure: PSMA-radioguided surgery
- Drug: ADT
Primary outcomes (1)
- measure
- Clinical progression-free survival (CPFS)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male, aged ≥ 18 years. * Hormone-sensitive recurrent prostate cancer after radical prostatectomy, external beam radiotherapy or brachytherapy * ≤ 2 lymph node metastases or local residual disease within the pelvis with sufficient PSMA expression (≥2 times regional vascular activity level) as determined by PSMA-based PET * PSA-value \< 4 ng/mL in case of a local recurrence and PSA \< 3 ng/ml in case of (a) nodal recurrence(s) * Had a PSMA PET/CT within 90 days before surgery * Suitable for salvage surgery, as per institutional guidelines. * Charlson Comorbidity Index ≤ 4 * World Health Organisation (WHO) performance status 0, 1, or 2. * Written and signed informed consent. Exclusion Criteria: * Other diagnosis of malignancy or evidence of other malignancy within 5 years before screening for this study (except non-melanoma skin cancer). * More than 2 lymph node metastases on PSMA PET/CT * Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery * Non-regional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT. * Castration resistance defined by clinical or biochemical progression despite a combined androgen blockade * Known contraindications to hormone therapy, according to standard recommendations in force * Patient with a psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule * Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery. * Severe claustrophobia interfering with PET/CT scanning. * Absence or withdrawal of an informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.