Surgery guided by imaging for recurrent prostate cancer

Tracer-Based Image Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial

This study is testing if a new type of surgery, guided by special imaging, can help men with recurring prostate cancer feel better when combined with hormone therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: The Netherlands Cancer Institute (Academic / other)
• Locations: 1 site (Amsterdam, Noord-Holland)
• Trial ID: NCT05555017 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of PSMA-radioguided surgery combined with androgen deprivation therapy (ADT) in men with recurrent prostate cancer. Participants will be randomized to receive either 6 months of ADT alone or ADT plus the surgical intervention. The study focuses on patients with localized disease recurrence, specifically those with limited lymph node metastases or local residual disease, as identified by PSMA PET/CT imaging. The goal is to improve treatment outcomes for patients experiencing biochemical recurrence after initial prostate cancer treatment.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with hormone-sensitive recurrent prostate cancer and limited lymph node involvement.

Not a fit: Patients with multiple lymph node metastases or other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved oncological outcomes for patients with recurrent prostate cancer.

How similar studies have performed: Previous studies using PSMA-guided approaches have shown promise, suggesting potential for success in this novel application.

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

Where this trial is running

Amsterdam, Noord-Holland

• Antoni van Leeuwenhoek Hospital — Amsterdam, Noord-Holland, Netherlands (Recruiting)

Study contacts

• Study coordinator: Pim van Leeuwen, MD, PhD

Conditions Prostate Cancer; PSMA-radioguided surgery; ADT; recurrent prostate cancer