Tracer-Guided Surgery for Recurrent Prostate Cancer (Trace-II)

Netherlands Cancer Institute (NKI)

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: ADT; Procedure: PSMA-radioguided surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05555017

N21TRA

Details and patient eligibility

About

ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Arm A: ADT

Active Comparator group

Description:

Patients in arm A will receive standard 6 months of ADT according to current clinical guidelines.

Treatment:

Drug: ADT

Arm B: ADT + PSMA radioguided surgery

Experimental group

Description:

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.

Treatment:

Drug: ADT

Procedure: PSMA-radioguided surgery