Prostate CancerTRACENCT03857113
Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study
An observational study of Prostate Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
PSMA-radioguided surgery 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
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Mar 2020to 1 Mar 2022
- Phase
- Observational
- 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
Study population: men with hormone-sensitive recurent prostate cancer
Who may be able to join
- Male, aged ≥ 18 years.
- Hormone-sensitive recurrent prostate cancer after radical prostatectomy
- <3 soft tissue lesions (lymph node; connective tissue) within the pelvis or retroperitoneum with sufficient PSMA expression (≥3 times regional vascular activity level) as determined by PSMA-based PET
- PSA-value <4ng/mL
- Had a PSMA PET/CT within 60 days before surgery
- Suitable for salvage lymph node dissection, as per institutional guidelines.
- WHO performance status 0,1, or 2.
- Written informed consent.
Who cannot join
- Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery
- Nonregional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT.
- Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery.
- Severe claustrophobia interfering with PET/CT or SPECT/CT scanning.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
AVL
Amsterdam, North Holland, 1066CX
Pim van Leeuwen, MD, PhD, +31205129111, pj.v.leeuwen@nki.nl
Maarten Donswijk, +31205127473, m.donswijk@nki.nl
About this study
Official title: 99mTechnetium Based PSMA-Radioguided Assisted Surgery for Prostate Cancer (TRACE) Feasibility Study
PSMA-radioguided surgery
Read the detailed description
Given the difficulty visualizing lymph node involvement with pre-operative imaging alone, and the potential to miss metastatic nodal involvement on template PLND, radioguided surgery has been proposed as a technique to improve intra-operative detection and clearance. 99mTechnetium (99mTc) is a frequently used radioisotope in nuclear medicine, with favourable radiation properties and commercial availability[11]. It has a 6-hour half-life, and is suited to allow target tissue accumulation, while minimizing patients and investigator radiation exposure. Novel molecule-targeted radiopharmaceuticals using 99mTC and other radioisotopes in the setting of PC have increasing potential for diagnostic imaging, monitoring of therapeutic interventions and directed surgery[11, 12]. In relation to radioguided surgery, 99mTC -based PSMA-radioguided surgery (99mTc-PSMA-RGS) was deployed in a feasibility study. Using a specifically designed 99mTc based tracer, 99mTc-mas3-y-nal-k(Sub-KuE), or in short Tc-99m-PSMA I\&S, combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases was undertaken in 132 patients, yielding a sensitivity of 84% and specificity of 100% and detecting metastases as small as 3mm[15, 16]. This raises the question as to whether a combination of PSMA PET/CT imaging and PSMA-radioguided surgery may increase the cure rate in patients undergoing operative management of PC, by increasing detection sensitivity and specificity of nodal metastases.
- Conditions
- Prostate Cancer
- Being tested
- PSMA-radioguided surgery
- 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
PSMA-radioguided surgery
| Study group | Role | What they receive |
|---|---|---|
| PSMA-radioguided surgery | Tc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases Receives: Procedure: PSMA-radioguided surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection
sensibility of 99mTc-PSMA-I\&S by calculating the percentage of PSMA avid lymph nodes
Measured: through study completion, an average of two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 Mar 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pim van Leeuwen, MD, PHD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857113
- Sponsor's protocol ID
- M19TRA
- Acronym
- TRACE
- Status last verified
- Jul 2020
- First submitted
- 19 Nov 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 99mTechnetium Based PSMA-Radioguided Assisted Surgery for Prostate Cancer (TRACE) Feasibility Study
- ClinicalTrials.gov ID
- NCT03857113
- Acronym / sponsor ID
- TRACE / M19TRA
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PSMA-radioguided surgery
Detailed description
Given the difficulty visualizing lymph node involvement with pre-operative imaging alone, and the potential to miss metastatic nodal involvement on template PLND, radioguided surgery has been proposed as a technique to improve intra-operative detection and clearance. 99mTechnetium (99mTc) is a frequently used radioisotope in nuclear medicine, with favourable radiation properties and commercial availability[11]. It has a 6-hour half-life, and is suited to allow target tissue accumulation, while minimizing patients and investigator radiation exposure. Novel molecule-targeted radiopharmaceuticals using 99mTC and other radioisotopes in the setting of PC have increasing potential for diagnostic imaging, monitoring of therapeutic interventions and directed surgery[11, 12]. In relation to radioguided surgery, 99mTC -based PSMA-radioguided surgery (99mTc-PSMA-RGS) was deployed in a feasibility study. Using a specifically designed 99mTc based tracer, 99mTc-mas3-y-nal-k(Sub-KuE), or in short Tc-99m-PSMA I\&S, combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases was undertaken in 132 patients, yielding a sensitivity of 84% and specificity of 100% and detecting metastases as small as 3mm[15, 16]. This raises the question as to whether a combination of PSMA PET/CT imaging and PSMA-radioguided surgery may increase the cure rate in patients undergoing operative management of PC, by increasing detection sensitivity and specificity of nodal metastases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA-radioguided surgery | – | Procedure: PSMA-radioguided surgeryTc-99m-PSMA combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men with hormone-sensitive recurent prostate cancer
Key inclusion criteria (8 listed)
- Male, aged ≥ 18 years.
- Hormone-sensitive recurrent prostate cancer after radical prostatectomy
- <3 soft tissue lesions (lymph node; connective tissue) within the pelvis or retroperitoneum with sufficient PSMA expression (≥3 times regional vascular activity level) as determined by PSMA-based PET
- PSA-value <4ng/mL
- Had a PSMA PET/CT within 60 days before surgery
Key exclusion criteria (4 listed)
- Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery
- Nonregional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT.
- Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery.
- Severe claustrophobia interfering with PET/CT or SPECT/CT scanning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA-radioguided surgeryPSMA-radioguided surgery | Procedure or surgery | PSMA-radioguided surgery |
Primary outcome
sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection
Time frame: through study completion, an average of two days
sensibility of 99mTc-PSMA-I\&S by calculating the percentage of PSMA avid lymph nodes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pim van Leeuwen, MD, PHD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 8 inclusion and 4 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 22 Jul 2020. 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.
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 (0205129111, 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?
sensibility of 99mTc-PSMA Radioguided surgery in lymph node dissection (time frame: through study completion, an average of two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2020.