Tracer-Guided Surgery for Recurrent Prostate Cancer

Trial Title: Tracer-Guided Surgery for Recurrent Prostate Cancer

NCT ID: NCT05555017

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
PSMA-radioguided surgery
ADT
recurrent prostate cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: PSMA-radioguided surgery
Description: Approximately 15-24 hours prior to surgery, 400-600 Megabecquerel (MBq) of 99mTc-PSMA-I&S will be intravenously administered to the patient at the Nuclear Medicine department. Following this injection patients will be allowed to return home, and then present for their 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery the next day.
Arm group label: Arm B: ADT + PSMA radioguided surgery

Intervention type: Drug
Intervention name: ADT
Description: Standard 6 months of ADT according to current clinical guidelines. ADT consists of one subcutaneous depot of 22,5mg triptorelin (Pamorelin), with 4 weeks bicalutamide 50mg per os from 2 weeks before till 2 weeks after the first Pamorelin administration.
Arm group label: Arm A: ADT
Arm group label: Arm B: ADT + PSMA radioguided surgery

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.

Criteria for 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Antoni van Leeuwenhoek Hospital

Address:
City: Amsterdam
Zip: 1066CX
Country: Netherlands

Status: Recruiting

Contact:
Last name: Pim van Leeuwen, MD/PhD

Phone: 020 512 9111
Email: pj.v.leeuwen@nki.nl

Contact backup:
Last name: Lotte Zuur, MD

Phone: 020 512 9111
Email: l.g.zuur@nki.nl

Start date: February 15, 2023

Completion date: November 2025

Lead sponsor:
Agency: The Netherlands Cancer Institute
Agency class: Other

Source: The Netherlands Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05555017