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Prostate CancerPhase 2NCT03396874

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

A Phase 2 study testing 68Ga-PSMA in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Michigan at 1 site in United States.

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 study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
68Ga-PSMA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,435 participants
Where
1 siteUnited States
Study dates
9 Feb 2018to 9 Aug 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histopathological proven prostate adenocarcinoma.
  • Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
  • Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.
  • Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
  • Karnofsky performance status of ≥ 50.
  • Age ≥ 18.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Who cannot join

  • Current investigational therapy for prostate cancer.
  • Unable to lie flat, still or tolerate a PET/CT scan.
  • Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.
  • Prisoner.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.

To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

Read the detailed description

This study evaluates Gallium-68 labelled PSMA-11 (also called Gallium-68 labelled PSMA-HBED-CC, or Gallium-68 labelled PSMA N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid), abbreviated here as 68Ga-PSMA. This molecule (or radiotracer) binds to receptors that are often present on prostate cancer cells. Using 68Ga-PSMA together with a positron emission tomography (PET) scanner (with computed tomography, called PET/CT), it is therefore possible to find prostate cancer lesions in the body. The study will test whether 68Ga-PSMA will identify prostate cancer more precisely than normal imaging methods (for example CT, MRI, or bone scan). A more precise identification of the location of the disease is important. Knowing where the disease is located will help to decide on the best course of action to treat the disease.

Men who have elevated tumor markers of prostate cancer are eligible for this study. Participants undergo a 68Ga-PSMA PET/CT scan before further treatment. Based on clinical information, including any prior imaging and biopsy/surgery information and follow-up information, we will determine whether 68Ga-PSMA PET/CT imaging was more accurate than the standard imaging. The study team will collect this information for up to 1 year after the 68Ga-PSMA PET/CT scan.

The results of the 68Ga-PSMA PET/CT scan will be shared with the participating patients. Also, results will be entered into the participant's medical record and shared with the treating physicians.

Being tested
68Ga-PSMA
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • 68Ga-PSMADrug

    Also called Gallium-68 PSMA-HBED-CC, Gallium-68 PSMA-11

    PET/CT imaging with 68Ga-PSMA:

    68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).

Study groups in NCT03396874
Study groupRoleWhat they receive
Patient participantsExperimentalPET/CT imaging
Receives: Drug: 68Ga-PSMA

What is being measured

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

  1. Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology.

    Evaluation of the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.

    The result of a histopathological examination of a PSMA positive lesion is obtained when available. Such data are collected as a single time point up to 12 months following the scan.

    Measured: Up to 12 months after 68Ga-PSMA scan

Secondary outcomes (4)

  1. Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location.

    The sensitivity and PPV of 68Ga-PSMA PET/CT is determined on a per-patient and per-region-basis for the detection of tumor location. Confirmation is obtained by conventional imaging, clinical follow-up, and/or histopathology/biopsy where available. Results of conventional imaging, clinical follow-up, and/or histopathology is collected as a single time point up to 12 months following the scan.

    Measured: Up to 12 months after 68Ga-PSMA scan

  2. Adverse Events of 68Ga-PSMA Administration

    The number of adverse events were determined through clinical assessment and categorized by CTCAE 4.0.

    Measured: 24 - 72 hours post administration

  3. Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT

    Scan detection rates (in %) on a per-patient basis are given for specific PSA value ranges (a) 0.2<0.5, b) 0.5<1.0, c) 1.0<2.0, d) 2.0<5.0, e) >=5.0 ng/mL. Ideally, the 68Ga-PSMA-11 PET/CT scan detection rate would be 100% at any PSA range.

    Measured: 12 months post scan

  4. Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients

    The results of this outcome measure were evaluated using a treatment plan questionnaire given to the treating physician or practitioner before the scan, at approximately 1 month (2-30 days) after the 68Ga-PSMA-11 PET scan, and at approximately 6 months (range 3 - 12 months) after the 68Ga-PSMA-11 PET scan. The treatment plan questionnaire was provided with 11 choice options. Responses to the questionnaire were compared to determine whether physicians changed their treatment plans following the PET scan.

    Measured: 2 days to 12 months following the scan.

Timeline

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

  1. First posted11 Jan 2018
  2. Study start9 Feb 2018
  3. Primary completion9 Aug 2022
  4. Study completion9 Aug 2022

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03396874
Sponsor's protocol ID
HUM125841
Status last verified
Oct 2023
First submitted
4 Jan 2018
Last updated
3 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Codified data will be archived and stored in an imaging repository with limited metadata for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.

Publications

  • Abghari-Gerst M, Armstrong WR, Nguyen K, Calais J, Czernin J, Lin D, Jariwala N, Rodnick M, Hope TA, Hearn J, Montgomery JS, Alva A, Reichert ZR, Spratt DE, Johnson TD, Scott PJH, Piert M. A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients. J Nucl Med. 2022 Apr;63(4):567-572. doi: 10.2967/jnumed.121.262412. Epub 2021 Jul 29.

    PubMed 34326126

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 68Ga-PSMA in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Michigan at 1 site in United States.

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 7 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: finished, as of the sponsor's last update on 3 Nov 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 United States. 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?

Yes. Results are posted in the registry (first posted 3 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology. (time frame: Up to 12 months after 68Ga-PSMA scan). 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 NCT03396874, 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 3 Nov 2023.

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