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Prostate CancerPhase 2Trace-IINCT05555017

Tracer-Guided Surgery for Recurrent Prostate Cancer

A Phase 2 study testing PSMA-radioguided surgery and ADT in people with Prostate Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
PSMA-radioguided surgery and ADT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteNetherlands
Study dates
15 Feb 2023to Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Charlson Comorbidity Index ≤ 4
  • World Health Organisation (WHO) performance status 0, 1, or 2.
  • Written and signed informed consent.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Pim van Leeuwen, MD, PhD contact

003125129111

pj.v.leeuwen@nki.nl

Lotte Zuur, MD contact

003125129111

l.zuur@nki.nl

Netherlands1 site, 1 recruiting

  • Antoni van Leeuwenhoek Hospital

    Amsterdam, North Holland, 1066CX

    Pim van Leeuwen, MD/PhD, 020 512 9111, pj.v.leeuwen@nki.nl

    Lotte Zuur, MD, 020 512 9111, l.g.zuur@nki.nl

    Recruiting

Other trials in Netherlands

About this study

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

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

Read the 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.

Conditions
Prostate Cancer
Being tested
PSMA-radioguided surgery, ADT
Keywords
PSMA-radioguided surgery, ADT, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSMA-radioguided surgeryProcedure or surgery

    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.

  • 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.

Study groups in NCT05555017
Study groupRoleWhat they receive
Arm A: ADTActive comparatorPatients in arm A will receive standard 6 months of ADT according to current clinical guidelines.
Receives: Drug: ADT
Arm B: ADT + PSMA radioguided surgeryExperimentalPatients 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.
Receives: Procedure: PSMA-radioguided surgery; Drug: ADT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (13)

  1. 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.

    Measured: 24 months

  2. 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)

    Measured: 24 months

  3. 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.

    Measured: 10 years

  4. Overall survival (OS)

    Overall survival will be read as the time from trial randomization to the date of death from any cause

    Measured: 10 years

  5. Incidence of adjuvant therapy

    ADT, radiation therapy or additional salvage surgery

    Measured: 10 years

  6. 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

    Measured: 24 months

  7. 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.

    Measured: 24 months

  8. Complications

    Assessment of 99mTc-PSMA-I\&S injection-related as well as surgery-related complication rate according to Clavien-Dindo.

    Measured: 30 and 90 days

  9. 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

    Measured: 24 months

  10. Specificity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation

    In percentage

    Measured: 30 days

  11. Sensitivity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation

    In percentage

    Measured: 30 days

  12. Positive Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation

    In percentage

    Measured: 30 days

  13. Negative Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation

    In percentage

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2022
  2. Study start15 Feb 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05555017
Sponsor's protocol ID
N21TRA
Acronym
Trace-II
Status last verified
Oct 2023
First submitted
15 Sep 2022
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PSMA-radioguided surgery and ADT in people with Prostate Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pim van Leeuwen, MD, PhD (003125129111, pj.v.leeuwen@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical progression-free survival (CPFS) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05555017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.

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