Tracer-Based Imaged Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial - TRACE II

Recruiting

• Conditions: prostate cancer; prostate carcinoma; 10038597; 10036958; 10025506

• Registration Number: NL-OMON56147
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• Male, aged >= 18 years.
• Hormone-sensitive recurrent PC after RP, external beam radiotherapy or
brachytherapy
• Less than 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
• 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
potentially situation 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: Not specified