prostate cancer prostate carcinoma
Conditions
Interventions
99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male, aged >= 18 years. • Hormone-sensitive recurrent PC after RP, external beam radiotherapy or brachytherapy • Less than 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
Exclusion criteria
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 potentially situation 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the Clinical Progression Free Survival (CPFS). CPFS is defined as time between start of treatment and the appearance of a recurrence (any N1 or M1) as suggested by PSMA PET/CT or symptoms related to progressive PC, or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Metastasis-free survival defined as the time between randomization and the appearance of a metastatic recurrence (any M1) as suggested by PSMA PET-CT. • Biochemical progression-free survival after randomization. • Castrate resistant prostate cancer (CRPC), defined as castrate serum testosterone2 ng/ml. • Overall survival. Overall survival will be read as the time from trial randomization to the date of death from any cause • Incidence of adjuvant therapy (ADT, radiation therapy or additional salvage surgeries). • Patient reported QOL as per EORTC-QLQ C30 and EPIC 26 • Assessment of 99mTc-PSMA-I&S injection-related as well as surgery-related 30- and 90-day complication rate according to Clavien-Dindo. • The number of in field recurrences (recurrence measured by use of PSMA PET/CT in the template of 99mTc-PSMA-RGS supported salvage surgery) in men with biochemical progression after 99mTc-PSMA-RGS • Performance (i.e. sensitivity, specificity, positive and negative predictive value) of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation. | — |
Countries
Netherlands
Outcome results
None listed