A Phase 2 interventional study of PSMA-radioguided surgery and ADT in Prostate Cancer, sponsored by The Netherlands Cancer Institute. Recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by The Netherlands Cancer Institute · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Patients in arm A will receive standard 6 months of ADT according to current clinical guidelines.
Drug: ADT
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.
Procedure: PSMA-radioguided surgery · Drug: ADT
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.
Clinical 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
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
Plan to share: No
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