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Prostate CancerPhase 1/2DETECTNCT04300673

Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients

A Phase 1/2 study testing Radio guided surgery (RGS) using Indium-labelled PSMA in people with Prostate Cancer and Lymph Node Metastases, run by Radboud University Medical Center at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The study is a prospective, single arm phase I/II study. The primary aim of this study is to evaluate the feasibility of 111In-PSMA I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastases based on pre-operative imaging. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Prostate Cancer, Lymph Node Metastases
What is being tested?
Radio guided surgery (RGS) using Indium-labelled PSMA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesNetherlands
Study dates
1 Sep 2020to 1 Apr 2023
Phase
Phase 1/2
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 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven cancer of the prostate, based on prostate biopsy-core analysis.
  • At least one 18F/68Ga-PSMA-PET/CT suspected positive metastasis in lymph nodes, located in the pelvic region.
  • Patient is scheduled and fit for robot assisted surgery (PLND or radical prostatectomy +PLND).
  • Patient is suitable for PLND (and radical prostatectomy) conform institutional guidelines and is not yet treated pre-operatively .
  • Age≥50 years.
  • Ability to give voluntary written informed consent to participate in this study.

Who cannot join

  • No detectable lesion on the 18F/68Ga-PSMA-PET/CT with an uptake level above liver uptake level (reference).
  • Patients who are not scheduled for robot-assisted PLND.
  • Prior pelvic surgery(1)
  • Unequivocal evidence of metastases outside the pelvic region.
  • Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients' clinical status by participating in this trial.
  • Prior prostate cancer treatment(2).
Show all 12Show fewer
  • Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators).
  • Inability to lie still for at least 60 minutes or comply with imaging.
  • Contraindication for iron infusion or hypersensitivity/allergy to the active substance or any of the excipients.
  • The patient is already enrolled in one or more concurrent studies, which could confound the results of this study, according to the investigators.
  • Pelvic surgery is defined as "any surgery associated with pelvic lymphadenopathy'.
  • Prior prostate cancer treatment is defined as prostate and/or pelvic radiotherapy, hormonal treatments such as androgen deprivation therapy, prostate brachytherapy, prostate cryotherapy, high intensity focused ultrasound (HIFU) and/or prostate electroporation.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Radboudumc

    Nijmegen, Gelderland, 6525

  • Canisius Wilhelimina Ziekenhuis

    Nijmegen

Other trials in Netherlands

About this study

The study is a prospective, single arm phase I/II study. The primary aim of this study is to evaluate the feasibility of 111In-PSMA I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastases based on pre-operative imaging.

Patients with prostate cancer who have a high risk of lymph node metastases based on PSMA PET/CT and scheduled for robot-assisted PLND (with or without prostatectomy) will be recruited. Eligible patients will receive an additional ferumoxtran-10 enhanced MRI to complement pre-operative imaging. Twenty-four hours before surgery, patients will receive the radiolabelled PSMA tracer. Pelvic Lymph node dissections are carried out according to standard of care procedures. During surgery, the surgeon will be provided with a gamma-probe to detect PSMA expressing lymph nodes in vivo. Dissected samples will be systematically assessed on tracer accumulation using the gamma-probe ex vivo. After surgery, the samples will be scanned in the small animal SPECT/CT and 7T-MRI. After scanning, samples will be presented to pathologists for pathological analysis according to standard of care including staining for PSMA expression. At 3 months after surgery, patients will undergo a PSMA-PET/CT. Up until one year after surgery patients will be followed according to standard of care-guidelines by 3-monthly serum-PSA measurements.

Being tested
Radio guided surgery (RGS) using Indium-labelled PSMA
Keywords
pelvic lymph node dissection (PLND), PSMA I&T, radio guided surgery (RGS)
Medical subject headings
Prostatic Neoplasms, Lymphatic Metastasis

What participants receive

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

  • Radio guided surgery (RGS) using Indium-labelled PSMAProcedure or surgery

    Approximately 24hours prior to surgery (PLND) patients receive a radiolabelled PSMA-tracer. During surgery, urologists will use a gamma-probe to detect PSMA-postitive tumour depostitions in pelvic lymph nodes.

Study groups in NCT04300673
Study groupRoleWhat they receive
All patientsExperimentalIntervention: radio guided surgery
Receives: Procedure: Radio guided surgery (RGS) using Indium-labelled PSMA

What is being measured

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

  1. Feasibility of 111In-PSMA-I&T radio guided surgery

    The primary aim of this study is to evaluate the feasibility of 111In-PSMA-I\&T radio guided surgery in patients diagnosed with prostate cancer who are highly suspected of having one or more pelvic lymph node metastasis/metastases based on pre-operative imaging. Feasibility will be defined as the ability to intra-operatively detect the lymph nodes (using a gamma probe) which were pre-operatively identified on PSMA-PET/CT

    Measured: 1 year

Secondary outcomes (6)

  1. The accuracy of 111In-PSMA-I&T radio guided surgery

    Accuracy will be expressed as sensitivity and specificity percentage. Test results of gamma probe (positive or negative) will be compared with histopathology (gold standard) (positive or negative: i.e. containing PSMA-expressing prostate cancer cells).

    Measured: 1 year

  2. The safety of 111In-PSMA-I&T

    Safety will be assesed by the number of participants with treatment related adverse events as assessed by CTCAE v4.0. For this outcome measure extra bloodsampling is included in the study protocol.

    Measured: 1 year

  3. Dosimetry of 111In-PSMA-I&T

    Blood-clearance ratios will be determined based on radiation dosimetry as assessed by bloodsampling at set time points after injection.

    Measured: 1 year

  4. Correlation between tracer accumulation and lymph node size, PSMA-staining and SUV on PSMA-PET/CT

    Measured: 1 year

  5. Correlation between post-operative nano-MRI and SPECT

    Measured: 1 year

  6. Correlation between pre-operative imaging and postoperative imaging

    Measured: 2 years

Timeline

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

  1. First posted9 Mar 2020
  2. Study start1 Sep 2020
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion1 Apr 2023 (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 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04300673
Sponsor's protocol ID
2019-5805
Other IDs
2019-003284-21, 2019
Acronym
DETECT
Status last verified
Apr 2022
First submitted
17 Feb 2020
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schilham MGM, Somford DM, Kusters-Vandevelde HVN, Hermsen R, van Basten JPA, Hoekstra RJ, Scheenen TWJ, Gotthardt M, Sedelaar JPM, Rijpkema M. Prostate-Specific Membrane Antigen-Targeted Radioguided Pelvic Lymph Node Dissection in Newly Diagnosed Prostate Cancer Patients with a Suspicion of Locoregional Lymph Node Metastases: The DETECT Trial. J Nucl Med. 2024 Mar 1;65(3):423-429. doi: 10.2967/jnumed.123.266495.

    PubMed 38176721

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radio guided surgery (RGS) using Indium-labelled PSMA in people with Prostate Cancer and Lymph Node Metastases, run by Radboud University Medical Center at 2 sites 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 6 inclusion and 12 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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of 111In-PSMA-I&T radio guided surgery (time frame: 1 year). 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 NCT04300673, which also lists 1 linked publication.

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 29 Apr 2022.

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