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Tracer-Guided Surgery for Recurrent Prostate Cancer (Trace-II)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
PSMA-radioguided surgery
ADT
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring PSMA-radioguided surgery, ADT, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Antoni van Leeuwenhoek HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: ADT

Arm B: ADT + PSMA radioguided surgery

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Metastasis-free survival (MFS)
Metastasis-free survival will be defined as the time between randomization and the appearance of a metastatic recurrence (any M1) as suggested by PSMA PET-CT.
Biochemical progression-free survival (BPFS)
Biochemical progression-free survival will be defined as the time between randomization and the development of biochemical progression ( three consecutive rises in prostate specific antigen (PSA) 1 week apart, resulting in two 50% increases over the nadir and PSA>2 ng/ml)
Castrate resistant prostate cancer (CRPC)
CRPC is defined as castrate serum testosterone<50 ng/dl plus biochemical progression, i.e., three consecutive rises in PSA 1 week apart, resulting in two 50% increases over the nadir and PSA>2 ng/ml.
Overall survival (OS)
Overall survival will be read as the time from trial randomization to the date of death from any cause
Incidence of adjuvant therapy
ADT, radiation therapy or additional salvage surgery
Patient reported QOL as per EORTC-QLQ C30
Quality of life (QoL) will be assessed with the EORTC Core Quality of Life questionnaire's (QLQ-C30) global QoL scale ranging from 0 to 100, higher scores indicate better QoL
Patient reported QOL as per Expanded Prostate cancer Index Composite (EPIC) 26
Quality of life (QoL) will be assessed with the EPIC 26 questionnaire, containing 26 items covering 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better QOL.
Complications
Assessment of 99mTc-PSMA-I&S injection-related as well as surgery-related complication rate according to Clavien-Dindo.
Number of in-field recurrences
Recurrence measured by use of PSMA PET/CT in the template of 99mTc-PSMA-radioguided surgery (RGS) supported salvage surgery
Specificity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
In percentage
Sensitivity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
In percentage
Positive Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
In percentage
Negative Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
In percentage

Full Information

First Posted
September 15, 2022
Last Updated
October 5, 2023
Sponsor
The Netherlands Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05555017
Brief Title
Tracer-Guided Surgery for Recurrent Prostate Cancer
Acronym
Trace-II
Official Title
Tracer-Based Image Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PSMA-radioguided surgery, ADT, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: ADT
Arm Type
Active Comparator
Arm Description
Patients in arm A will receive standard 6 months of ADT according to current clinical guidelines.
Arm Title
Arm B: ADT + PSMA radioguided surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PSMA-radioguided surgery
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
ADT
Intervention 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.
Primary Outcome Measure Information:
Title
Clinical progression-free survival (CPFS)
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Metastasis-free survival (MFS)
Description
Metastasis-free survival will be defined as the time between randomization and the appearance of a metastatic recurrence (any M1) as suggested by PSMA PET-CT.
Time Frame
24 months
Title
Biochemical progression-free survival (BPFS)
Description
Biochemical progression-free survival will be defined as the time between randomization and the development of biochemical progression ( three consecutive rises in prostate specific antigen (PSA) 1 week apart, resulting in two 50% increases over the nadir and PSA>2 ng/ml)
Time Frame
24 months
Title
Castrate resistant prostate cancer (CRPC)
Description
CRPC is defined as castrate serum testosterone<50 ng/dl plus biochemical progression, i.e., three consecutive rises in PSA 1 week apart, resulting in two 50% increases over the nadir and PSA>2 ng/ml.
Time Frame
10 years
Title
Overall survival (OS)
Description
Overall survival will be read as the time from trial randomization to the date of death from any cause
Time Frame
10 years
Title
Incidence of adjuvant therapy
Description
ADT, radiation therapy or additional salvage surgery
Time Frame
10 years
Title
Patient reported QOL as per EORTC-QLQ C30
Description
Quality of life (QoL) will be assessed with the EORTC Core Quality of Life questionnaire's (QLQ-C30) global QoL scale ranging from 0 to 100, higher scores indicate better QoL
Time Frame
24 months
Title
Patient reported QOL as per Expanded Prostate cancer Index Composite (EPIC) 26
Description
Quality of life (QoL) will be assessed with the EPIC 26 questionnaire, containing 26 items covering 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better QOL.
Time Frame
24 months
Title
Complications
Description
Assessment of 99mTc-PSMA-I&S injection-related as well as surgery-related complication rate according to Clavien-Dindo.
Time Frame
30 and 90 days
Title
Number of in-field recurrences
Description
Recurrence measured by use of PSMA PET/CT in the template of 99mTc-PSMA-radioguided surgery (RGS) supported salvage surgery
Time Frame
24 months
Title
Specificity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
Description
In percentage
Time Frame
30 days
Title
Sensitivity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
Description
In percentage
Time Frame
30 days
Title
Positive Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
Description
In percentage
Time Frame
30 days
Title
Negative Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation
Description
In percentage
Time Frame
30 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pim van Leeuwen, MD, PhD
Phone
003125129111
Email
pj.v.leeuwen@nki.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Lotte Zuur, MD
Phone
003125129111
Email
l.zuur@nki.nl
Facility Information:
Facility Name
Antoni van Leeuwenhoek Hospital
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pim van Leeuwen, MD/PhD
Phone
020 512 9111
Email
pj.v.leeuwen@nki.nl
First Name & Middle Initial & Last Name & Degree
Lotte Zuur, MD
Phone
020 512 9111
Email
l.g.zuur@nki.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tracer-Guided Surgery for Recurrent Prostate Cancer

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