NCT05555017

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

September 15, 2022

Last Update Submit

October 5, 2023

Conditions

Prostate Cancer

Keywords

PSMA-radioguided surgeryADTrecurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical progression-free survival (CPFS)

    CPFS is defined as time between randomization and the appearance of a recurrence (any N1 or M1) as suggested by PSMA PET/CT or symptoms related to progressive PC, or death due to any cause

    24 months

Secondary Outcomes (13)

  • Metastasis-free survival (MFS)

    24 months

  • Biochemical progression-free survival (BPFS)

    24 months

  • Castrate resistant prostate cancer (CRPC)

    10 years

  • Overall survival (OS)

    10 years

  • Incidence of adjuvant therapy

    10 years

  • +8 more secondary outcomes

Study Arms (2)

Arm A: ADT

ACTIVE COMPARATOR

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

Drug: ADT

Arm B: ADT + PSMA radioguided surgery

EXPERIMENTAL

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 surgeryDrug: ADT

Interventions

PSMA-radioguided surgeryPROCEDURE

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 B: ADT + PSMA radioguided surgery
ADTDRUG

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 A: ADTArm B: ADT + PSMA radioguided surgery

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antoni van Leeuwenhoek Hospital

Amsterdam, North Holland, 1066CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Pim van Leeuwen, MD, PhD

CONTACT

003125129111pj.v.leeuwen@nki.nl

Lotte Zuur, MD

CONTACT

003125129111l.zuur@nki.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 26, 2022

Study Start

February 15, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)