Overview
ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.
Description
Improving the oncological treatment outcomes in men with a biochemical recurrence after primary prostate cancer (PC) treatment that are diagnosed with a disease recurrence confined to the regional lymph nodes or local residual disease using Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography and Computed Tomography (PET/CT.)
The proposed trial randomizes patients with recurrent PC following primary PC treatment to either 6 months of ADT or Technetium-PSMA-radioguided salvage surgery plus 6 months of ADT. Although the optimal duration of ADT is unknown, a minimal duration of 6 months of ADT seems advisable in this setting and will be mandatory for both arms.
Eligibility
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