Tracer-Guided Surgery for Recurrent Prostate Cancer

Launched by THE NETHERLANDS CANCER INSTITUTE · Sep 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called tracer-guided surgery for men with recurrent prostate cancer. Specifically, it looks at how well a type of surgery, assisted by robotic technology and guided by a special imaging method (PSMA PET), works alongside hormone therapy to treat patients whose cancer has returned after previous treatments. The trial is currently recruiting male participants aged 18 and older who have hormone-sensitive recurrent prostate cancer and meet certain health criteria.

To be eligible for this study, participants should have up to two lymph node metastases or localized disease and must have undergone a PSMA PET scan within the last 90 days. They need to have a specific level of prostate-specific antigen (PSA) that indicates a low level of cancer activity. Participants can expect to receive hormone therapy and possibly the new surgery technique, with careful monitoring throughout the trial. It’s important to note that individuals with certain other health conditions or cancers may not qualify, and those currently receiving hormone therapy or with severe claustrophobia that would interfere with imaging cannot participate. Overall, this trial aims to improve treatment options for men facing recurrent prostate cancer.

Gender

MALE

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