Tracer-Guided Surgery for Recurrent Prostate Cancer
- Registration Number
- NCT05555017
- Lead Sponsor
- The Netherlands Cancer Institute
- Brief Summary
ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 60
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: ADT + PSMA radioguided surgery PSMA-radioguided surgery 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. Arm B: ADT + PSMA radioguided surgery 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. Arm A: ADT ADT Patients in arm A will receive standard 6 months of ADT according to current clinical guidelines.
- Primary Outcome Measures
Name Time Method Clinical progression-free survival (CPFS) 24 months 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
- Secondary Outcome Measures
Name Time Method Metastasis-free survival (MFS) 24 months 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.
Incidence of adjuvant therapy 10 years ADT, radiation therapy or additional salvage surgery
Complications 30 and 90 days Assessment of 99mTc-PSMA-I\&S injection-related as well as surgery-related complication rate according to Clavien-Dindo.
Number of in-field recurrences 24 months Recurrence measured by use of PSMA PET/CT in the template of 99mTc-PSMA-radioguided surgery (RGS) supported salvage surgery
Biochemical progression-free survival (BPFS) 24 months 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)
Castrate resistant prostate cancer (CRPC) 10 years 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.
Overall survival (OS) 10 years Overall survival will be read as the time from trial randomization to the date of death from any cause
Patient reported QOL as per EORTC-QLQ C30 24 months 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
Specificity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation 30 days In percentage
Patient reported QOL as per Expanded Prostate cancer Index Composite (EPIC) 26 24 months 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.
Sensitivity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation 30 days In percentage
Positive Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation 30 days In percentage
Negative Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation 30 days In percentage
Trial Locations
- Locations (1)
Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Noord-Holland, Netherlands