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NCT05555017 | Recruiting | Prostate Cancer

Tracer-Guided Surgery for Recurrent Prostate Cancer
Sponsor:

The Netherlands Cancer Institute

Brief Summary:

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

Condition or disease

Prostate Cancer

Intervention/treatment

PSMA-radioguided surgery

ADT

Phase

Phase 2

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.}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Tracer-Based Image Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial
Actual Study Start Date : February 15, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2025
Arm Intervention/treatment

Active Comparator: Arm A: ADT

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

Drug: ADT

Experimental: Arm B: ADT + PSMA radioguided surgery

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.

Procedure: PSMA-radioguided surgery
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
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
Tracer-Guided Surgery for Recurrent Prostate Cancer

Location Details

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Tracer-Guided Surgery for Recurrent Prostate Cancer

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Netherlands, North Holland

Antoni van Leeuwenhoek Hospital

Amsterdam, North Holland, Netherlands, 1066CX