ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Approximately 15-24 hours prior to surgery, 400-600 Megabecquerel (MBq) of 99mTc-PSMA-I\&S will be intravenously administered to the patient at the Nuclear Medicine department. Following this injection patients will be allowed to return home, and then present for their 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery the next day.
Standard 6 months of ADT according to current clinical guidelines. ADT consists of one subcutaneous depot of 22,5mg triptorelin (Pamorelin), with 4 weeks bicalutamide 50mg per os from 2 weeks before till 2 weeks after the first Pamorelin administration.
Antoni van Leeuwenhoek Hospital
Amsterdam, North Holland, Netherlands
RECRUITINGClinical progression-free survival (CPFS)
CPFS is defined as time between randomization 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
Time frame: 24 months
Metastasis-free survival (MFS)
Metastasis-free survival will be defined as the time between randomization and the appearance of a metastatic recurrence (any M1) as suggested by PSMA PET-CT.
Time frame: 24 months
Biochemical progression-free survival (BPFS)
Biochemical progression-free survival will be defined as the time between randomization and the development of biochemical progression ( three consecutive rises in prostate specific antigen (PSA) 1 week apart, resulting in two 50% increases over the nadir and PSA\>2 ng/ml)
Time frame: 24 months
Castrate resistant prostate cancer (CRPC)
CRPC is defined as castrate serum testosterone\<50 ng/dl plus biochemical progression, i.e., three consecutive rises in PSA 1 week apart, resulting in two 50% increases over the nadir and PSA\>2 ng/ml.
Time frame: 10 years
Overall survival (OS)
Overall survival will be read as the time from trial randomization to the date of death from any cause
Time frame: 10 years
Incidence of adjuvant therapy
ADT, radiation therapy or additional salvage surgery
Time frame: 10 years
Patient reported QOL as per EORTC-QLQ C30
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Quality of life (QoL) will be assessed with the EORTC Core Quality of Life questionnaire's (QLQ-C30) global QoL scale ranging from 0 to 100, higher scores indicate better QoL
Time frame: 24 months
Patient reported QOL as per Expanded Prostate cancer Index Composite (EPIC) 26
Quality of life (QoL) will be assessed with the EPIC 26 questionnaire, containing 26 items covering 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better QOL.
Time frame: 24 months
Complications
Assessment of 99mTc-PSMA-I\&S injection-related as well as surgery-related complication rate according to Clavien-Dindo.
Time frame: 30 and 90 days
Number of in-field recurrences
Recurrence measured by use of PSMA PET/CT in the template of 99mTc-PSMA-radioguided surgery (RGS) supported salvage surgery
Time frame: 24 months
Specificity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
In percentage
Time frame: 30 days
Sensitivity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
In percentage
Time frame: 30 days
Positive Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
In percentage
Time frame: 30 days
Negative Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
In percentage
Time frame: 30 days