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High-risk Prostate CancerPhase 1/2NCT03362359

Ga-68-PSMA-11 in High-risk Prostate Cancer

A Phase 1/2 study testing Ga-68-PSMA-11 in people with High-risk Prostate Cancer and Prostate Cancer, run by German Cancer Research Center at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Ga-68-PSMA-11
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
8 sitesin 2 countries
Study dates
9 Oct 2017to 6 Jul 2020
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Male ≥ 18 years of age.
  • Histologically confirmed adenocarcinoma of the prostate.
  • High risk for metastasis, defined by either:
  • stadium cT3 according to TNM (primary tumor, regional nodes, metastasis) Classification of Malignant Tumours (TNM), or
  • Gleason Score >7, or
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  • Prostate-Specific Antigen (PSA) >20 ng/mL.
  • Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7 - 60 days after start of study.
  • Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
  • Preoperative PCA staging performed according to guidelines, to include a mandatory 99mTc bone scintigraphy and an optional pelvic MRI or CT, not older than 56 days prior to inclusion, according to standard of care.

Who cannot join

  • Known hypersensitivity to Ga-68-PSMA-11 or its components.
  • Presence of known lymph node metastases outside surgical field.
  • More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
  • Previous prostate cancer therapy.
  • Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
  • Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
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  • Evidence of neuroendocrine small cell carcinoma.
  • Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).
  • Simultaneous participation in other clinical trials

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Germany7 sites

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Friedrich-Alexander-Universität Erlangen

    Erlangen, 91054

  • Universität Duisburg-Essen

    Essen, 45147

  • Albert-Ludwigs-Universität Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Technische Universität München Klinikum rechts der Isar

    München, 81675

  • Eberhard-Karls-Universität Tübingen

    Tübingen, 72076

Other trials in Germany

Austria1 site

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

Other trials in Austria

About this study

Official title: An Open-label, Single-arm, Rater-blinded, Multicenter Phase 1/2 Study to Assess Safety and Diagnostic Accuracy and Radiotherapeutic Implications of Pre-operative Ga-68-PSMA-11 PET/CT Imaging in Comparison to Histopathology, in Newly-diagnosed Prostate Cancer (PCA) Patients at High Risk for Metastasis, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (EPLND)

This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive histopathology covering prostate and the tributary pelvic lymph node system, will be used. Therefore, only patients scheduled for RP with EPLND (as part of their standard of care) will be eligible.

Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to European Association of Urology (EAU) guideline [Mottet et al. 2015] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy.

In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.

Being tested
Ga-68-PSMA-11
Keywords
prostatectomy, 68Ga-PSMA-11, EPLND
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Ga-68-PSMA-11Drug

    Also called 68Ga-DKFZ-PSMA, 68Ga-PSMA, 68Ga-PSMA(HBED), Glu-NH-CO-NH-Lys-(Ahx)-[68Ga(HBED-CC)]

    Single administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg. A 2nd administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg is possible in the unlikely case of a negative histological result (i.e. no prostate-specific membrane antigen (PSMA) expression in dissected lymph nodes) to verify if PSMA PET-positive tissue as seen on day 1 has not been removed during RP with EPLND.

Study groups in NCT03362359
Study groupRoleWhat they receive
Ga-68-PSMA-11ExperimentalNot described
Receives: Drug: Ga-68-PSMA-11

What is being measured

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

  1. True positive fraction (TPF) and false positive fraction (FPF) of identified tumour tissue in soft tissue, analysed separately for prostate gland and pelvic lymph nodes, using histopathology as standard of truth.

    Measured: up to day 21

  2. Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, pulse oximetry, clinical laboratory, adverse events, concomitant medication).

    Measured: Day 0 - Day 7

Secondary outcomes (4)

  1. Number of identified bone lesions, per patient.

    Measured: Day 1

  2. Correlation coefficient of recovery-corrected standardized uptake values (SUV) plotted against Gleason score in primaries after RP

    Measured: Day 1

  3. Percentage of subjects for whom the RP and EPLND will not be conducted

    Measured: Day 1

  4. Quantity of circulating tumour cells in blood

    Measured: Day 1

Timeline

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

  1. First posted5 Dec 2017
  2. Study start9 Oct 2017
  3. Primary completion6 Jul 2020
  4. Study completion6 Jul 2020

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
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03362359
Sponsor's protocol ID
Ga-68-PSMA-11
Status last verified
Jul 2020
First submitted
18 Oct 2017
Last updated
27 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ga-68-PSMA-11 in people with High-risk Prostate Cancer and Prostate Cancer, run by German Cancer Research Center at 8 sites in 2 countries.

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 10 inclusion and 9 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: finished, as of the sponsor's last update on 27 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 8 sites in Germany, Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

True positive fraction (TPF) and false positive fraction (FPF) of identified tumour tissue in soft tissue, analysed separately for prostate gland and pelvic lymph nodes, using histopathology as standard of truth. (time frame: up to day 21). The study lists 2 primary outcomes in all. 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 NCT03362359.

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 27 Jul 2020.

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