Tracer-Guided Surgery for Recurrent Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute

Criteria

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