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Prostate AdenocarcinomaEarly Phase 1NCT04976257

Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

A Early Phase 1 study testing Angiogram, Catheterization and Gallium Ga-labeled PSMA-11 in people with Prostate Adenocarcinoma and Prostate Carcinoma, run by Ryan Kohlbrenner, MD 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

Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
Angiogram, Catheterization and Gallium Ga-labeled PSMA-11
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
13 Oct 2021to 22 Mar 2023
Phase
Early Phase 1
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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age greater than or equal to 18 years and less than or equal to 80 years.
  • Children are excluded from this study because the disease does not occur in children
  • Individuals from age 76 to age 80 must have a prior CT of the abdomen and pelvis within 5 years of first PSMA scan demonstrating non-occlusive pelvic atherosclerosis, regardless of smoking status
  • Individuals over the age of 80 are excluded from this study to improve the likelihood of a catheterizable prostatic artery, given the higher rates of occlusive atherosclerosis with advanced age
  • Ability to provide informed consent
  • Biopsy-proven unilateral or bilateral prostate adenocarcinoma, any stage (any N or any M)
Show all 11Show fewer
  • Large tumor burden, characterized by either
  • A discrete lesion with maximal tumor diameter >= 2.0cm on at least one affected side, documented on prostate magnetic resonance imaging (MRI) or Transrectal ultrasound (TRUS) within 4 months of first scan.
  • Infiltrative disease with primary pattern Gleason 4 adenocarcinoma in at least 4 of 6 sextant core biopsy locations on at least one affected side, documented in a surgical pathology report within 4 months of first scan.
  • Gleason score >= 4+4
  • Cancer of the Prostate Risk Assessment (CAPRA) score >= 6

Who cannot join

  • Body mass index (BMI) > 35 kg/m^2
  • Prior treatment for prostate cancer, or any use of anti-androgen therapy within 3 months of first scan
  • History of any pelvic radiotherapy
  • Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.
  • Stage IV or V chronic kidney disease by estimated glomerular filtration rate (eGFR) within 45 days of first scan
  • Platelet count < 50 x 10^9/L and/or international normalized ratio > 1.5
Show all 9Show fewer
  • Severe allergy to iodinated contrast
  • Active urinary tract infection or recent episode of prostatitis within 1 month of first scan
  • Inability to tolerate prolonged supine positioning

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients

Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the maximum standardized uptake value (SUVmax) in tumoral regions-of-interest during prostatic arterial and intravenous 68Ga-PSMA-11 infusions.

SECONDARY OBJECTIVES:

  1. To compare the tumoral time-activity curves for selective prostatic arterial and intravenous 68Ga-PSMA-11 infusions.

II. To study PSMA receptor saturation kinetics during selective prostatic arterial infusion of 68Ga-PSMA-11 (obtained only from arterial time activity curves [TACs] ipsilateral to the side of infusion).

OUTLINE:

Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. 1-14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.

After completion of study, patients are followed up with 24 hours after the IA infusion and PET scan.

Being tested
Angiogram, Catheterization, Gallium Ga-labeled PSMA-11, Positron Emission Tomography
Keywords
Ga68-PSMA-11
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • AngiogramProcedure or surgery

    Undergo angiogram

  • CatheterizationProcedure or surgery

    Undergo prostatic arterial catheterization

  • Gallium Ga-labeled PSMA-11Drug

    Also called 68Ga-PSMA-11

    Given IV and IA

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET scan

Study groups in NCT04976257
Study groupRoleWhat they receive
Ga-PSMA-11, PET/CT, Angiogram, and Prostatic Arterial CatheterizationExperimentalPatients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. One to 14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.
Receives: Procedure: Angiogram; Procedure: Catheterization; Drug: Gallium Ga-labeled PSMA-11; Procedure: Positron Emission Tomography

What is being measured

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

  1. Maximum standardized uptake value (SUVmax)

    A two-sided paired t-test will determine whether the ipsilateral SUVmax values obtained during selective arterial 68Ga-PSMA-11 infusions are greater than those obtained during venous infusions. A similar paired analysis will be made during arterial infusions to compare tumoral regions of interest (ROIs) ipsilateral and contralateral to the side of the infusion. Means/medians, ranges/standard deviations will be calculated for each endpoint.

    Measured: Day 1 and from Day 2 up to Day 15 (2 days total)

Secondary outcomes (7)

  1. Comparison of Mean SUV (SUVmean)

    Paired t-tests will determine whether SUVmean is different for intra-arterial (IA) time activity curves (TACs) when compared to intravenous (IV) TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

    Measured: Day 1 and from Day 2 up to Day 15 (2 days total)

  2. Comparison of Time to SUVmax (TSUV)

    Paired t-tests will determine whether TSUV is different for IA TACs when compared to IV TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

    Measured: Day 1 and from Day 2 up to Day 15 (2 days total)

  3. Comparison of Area under the curve (AUC)

    Paired t-tests will determine whether AUCs are different for IA TACs when compared to IV TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

    Measured: Day 1 and from Day 2 up to Day 15 (2 days total)

  4. Comparison of Rate of 68Ga-PSMA-11 uptake

    To assess whether the rate of uptake is significantly different with selective arterial infusion, a two-sided paired t-test will compare the slopes for Selective arterial infusion, tumor ipsilateral to the side of radiotracer injection (IAIpsi) curves and Intravenous infusion, tumor ipsilateral to the side of corresponding arterial injection (IVIpsi) curves during each of the nine time intervals. Selective arterial infusion, tumor contralateral to the side of radiotracer injection (IACont) slopes will be similarly compared to those acquired from corresponding Intravenous infusion, tumor contralateral to the side of corresponding arterial injection (IVCont) data. Means/medians, ranges/standard deviations will be calculated for each endpoint.

    Measured: Day 1 and from Day 2 up to Day 15 (2 days total)

  5. Comparison of Time to early saturation effects

    Specific to the IAIpsi TACs, the time to early saturation effects (Tese) will represent the time at which the second derivative of the curve becomes negative (i.e. when concavity in the curve is first noted). For the purposes of Tese, the aforementioned curve partitioning method will not be used. Descriptive statistics of Tese will be established, along with statistics for the corresponding mass dose administered (MDese) at Tese. Means/medians, ranges/standard deviations will be calculated for each endpoint.

    Measured: 1 day

  6. Comparison of Mass dose at saturation

    Descriptive statistics of Tese will be established, along with statistics for the corresponding mass dose administered (MDese) at Tese. Means/medians, ranges/standard deviations will be calculated for each endpoint.

    Measured: Day 1 and from Day 2 up to Day 15 (2 days total)

  7. Comparison of Mean SUV during 15-minute washout (SUVwashout)

    The mean SUVwashout and its standard deviation will be calculated for the 15-minute post-injection periods.

    Measured: 1 day

Timeline

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

  1. First posted26 Jul 2021
  2. Study start13 Oct 2021
  3. Primary completion22 Mar 2023
  4. Study completion22 Mar 2023

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04976257
Sponsor's protocol ID
21921
Other IDs
NCI-2021-06580
Status last verified
Apr 2023
First submitted
14 Jul 2021
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Magnuska ZA, Roy R, Palmowski M, Kohlen M, Winkler BS, Pfeil T, Boor P, Schulz V, Krauss K, Stickeler E, Kiessling F. Combining Radiomics and Autoencoders to Distinguish Benign and Malignant Breast Tumors on US Images. Radiology. 2024 Sep;312(3):e232554. doi: 10.1148/radiol.232554.

    PubMed 39254446

  • Kohlbrenner R, Wu X, Nguyen HG, Cooperberg MR, Chakravarty T, Carroll PR, Hope TA. Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA PET/CT Radioligand Infusions in Primary Prostatic Adenocarcinoma. Radiology. 2024 Aug;312(2):e232544. doi: 10.1148/radiol.232544.

    PubMed 39136560

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Angiogram, Catheterization and Gallium Ga-labeled PSMA-11 in people with Prostate Adenocarcinoma and Prostate Carcinoma, run by Ryan Kohlbrenner, MD 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 11 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 7 Apr 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Maximum standardized uptake value (SUVmax) (time frame: Day 1 and from Day 2 up to Day 15 (2 days total)). 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 NCT04976257, which also lists 2 linked publications.

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 7 Apr 2023.

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