Clinical trial NCT05555017: Tracer-Guided Surgery for Recurrent Prostate Cancer
Official title: Tracer-Based Image Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: PSMA-radioguided surgery
ADT
recurrent prostate cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical progression-free survival (CPFS)
timeFrame: 24 months
Secondary outcomes:
measure: Metastasis-free survival (MFS)
timeFrame: 24 months
measure: Biochemical progression-free survival (BPFS)
timeFrame: 24 months
measure: Castrate resistant prostate cancer (CRPC)
timeFrame: 10 years
measure: Overall survival (OS)
timeFrame: 10 years
measure: Incidence of adjuvant therapy
timeFrame: 10 years
measure: Patient reported QOL as per EORTC-QLQ C30
timeFrame: 24 months
measure: Patient reported QOL as per Expanded Prostate cancer Index Composite (EPIC) 26
timeFrame: 24 months
measure: Complications
timeFrame: 30 and 90 days
measure: Number of in-field recurrences
timeFrame: 24 months
measure: Specificity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
timeFrame: 30 days
measure: Sensitivity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
timeFrame: 30 days
measure: Positive Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
timeFrame: 30 days
measure: Negative Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
timeFrame: 30 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek Hospital
state: Noord-Holland
Study officials:
References: