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AzTrials

Biochemically Recurrent Prostate CarcinomaPhase 2NCT04928820

68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy

A Phase 2 study testing Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Malignant Neoplasm in the Bone, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
16 Jun 2021to 18 Oct 2022
Phase
Phase 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

  • Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen [PSA] level >= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)
  • Patients with bone scan scheduled or performed
  • Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between
  • Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized
  • Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent

Who cannot join

  • Initiation of a new therapy between the PSMA PET/CT and the bone scans
  • Inability to provide written informed consent
  • Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California at Los Angeles / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT With 99mTc-MDP Bone Scan and CT for Detection of M1b Disease in Prostate Cancer Patients With Biochemical Progression During ADT

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression.

SECONDARY OBJECTIVES:

  1. To compare the number of lesions rated as positive for bone metastases between the two imaging tests.

II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c).

III. To compare the positive predictive value (PPV) per-patient in patients with lesion validation (follow-up imaging or biopsy).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT.

Being tested
Computed Tomography, Gallium Ga 68 Gozetotide, Positron Emission Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo PET/CT

  • Gallium Ga 68 GozetotideOther

    Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC

    Given IV

  • Positron Emission TomographyProcedure or surgery

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

    Undergo PET/CT

Study groups in NCT04928820
Study groupRoleWhat they receive
Diagnostic (68Ga-PSMA-11 PET/CT)ExperimentalPatients receive gallium Ga 68 gozetotide IV. After 50-100 minutes, patients undergo whole body PET/CT.
Receives: Procedure: Computed Tomography; Other: Gallium Ga 68 Gozetotide; Procedure: Positron Emission Tomography

What is being measured

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

  1. Per-patient detection rate of gallium Ga 68 gozetotide (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)

    68Ga-PSMA-11 PET will be compared to bone scan/CT for M1b disease in prostate cancer patients progressing during androgen deprivation therapy. Patients who have at least one positive bone lesion will be rated positive. Patients will be treated as binary categorization. The analysis of the primary objective will utilize the McNemar's test to compare the detection rate between the imaging techniques.

    Measured: Up to 4 years

Secondary outcomes (6)

  1. Number of lesions found by PSMA PET and bone scan + CT

    Will be compared using a paired samples t-test.

    Measured: Up to 4 years

  2. Rate of M1 detection

    Will be compared between the two modalities, defined as the number of patients with positive finding(s) for M1 disease (M1a or M1b or M1c), will utilize the McNemar's test for paired proportions.

    Measured: Up to 4 years

  3. Per-patient positive predictive value (PPV)

    Per-patient PPV estimates (with 95% confidence interval), defined as the number true positive findings the total number of positive cases (TP + FP). The lesions will be considered true positive on the basis of biopsy information, follow-up imaging, or changes in prostate specific antigen (PSA) levels. This information will only be available in a small subset of patients.

    Measured: Up to 4 years

  4. PSA progression-free survival (PFS)

    Univariate Cox proportional hazards models for PFS will be constructed with models containing various patient characteristics as well as PSMA PET parameters and bone scan parameters. Hazard ratios with 95% confidence intervals as well as p-values will be tabulated. Next, will explore multivariate models (using LASSO variable selection) including terms for important baseline characteristics as well as PSMA parameters or bone scan parameters and will extract the survival concordance indices from each of these models and compare them.

    Measured: Up to 4 years

  5. Overall survival (OS)

    Univariate Cox proportional hazards models for OS will be constructed with models containing various patient characteristics as well as PSMA PET parameters and bone scan parameters. Hazard ratios with 95% confidence intervals as well as p-values will be tabulated. Next, will explore multivariate models (using LASSO variable selection) including terms for important baseline characteristics as well as PSMA parameters or bone scan parameters and will extract the survival concordance indices from each of these models and compare them.

    Measured: Up to 4 years

  6. Incidence of adverse events

    Assessed using Common Terminology Criteria for Adverse Events version 4.03.

    Measured: Up to 4 years

Timeline

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

  1. First posted16 Jun 2021
  2. Study start16 Jun 2021
  3. Primary completion18 Oct 2022
  4. Study completion18 Oct 2022

Why it stopped: slow recruitment

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04928820
Sponsor's protocol ID
21-000102
Other IDs
NCI-2021-03575
Status last verified
Oct 2022
First submitted
10 Jun 2021
Last updated
21 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nikitas J, Gafita A, Benz MR, Djaileb L, Farolfi A, Hotta M, Sonni I, Alano R, Rettig M, Shen J, Armstrong W, Grogan T, Liu S, Czernin J, Calais J. Phase 2 trial of PSMA PET CT versus planar bone scan and CT in prostate cancer patients progressing while on androgen deprivation therapy. Sci Rep. 2024 Oct 18;14(1):24411. doi: 10.1038/s41598-024-75589-6.

    PubMed 39420060

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Malignant Neoplasm in the Bone, run by Jonsson Comprehensive Cancer Center 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Oct 2022. 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?

The study was stopped early (reason given: slow recruitment). 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?

Per-patient detection rate of gallium Ga 68 gozetotide (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) (time frame: Up to 4 years). 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 NCT04928820, 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 21 Oct 2022.

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