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Biochemically Recurrent Prostate CarcinomaPhase 2NCT04050215

68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

A Phase 2 study testing Computed Tomography, Gallium Ga 68-labeled PSMA-11 and Positron Emission Tomography in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center 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 phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer. 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-labeled PSMA-11 and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
937 participants
Where
1 siteUnited States
Study dates
2 Apr 2018to 27 Sep 2021
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

  • Patients who fulfill criteria for initial staging or restaging as outlined below:
  • Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:
  • Surgery
  • External radiation therapy (RT)
  • Other focal therapies
  • Systemic medical treatment
Show all 17Show fewer
  • Watchful waiting
  • Assessment for subsequent treatment strategy (restaging), any of the following:
  • Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:
  • Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
  • Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA
  • Patients with known prostate cancer who undergo restaging because of new symptoms
  • Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging
  • Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed
  • Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision
  • Capability to provide written informed consent
  • Able to remain still for duration of each imaging procedure (about 30 minutes)

Who cannot join

  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
  • Inability to provide written informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Impact of 68GA-PSMA-11 PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer

This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

After completion of study, patients are followed up within 3-12 months.

Being tested
Computed Tomography, Gallium Ga 68-labeled PSMA-11, Positron Emission Tomography, Questionnaire Administration
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-labeled PSMA-11Drug

    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

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04050215
Study groupRoleWhat they receive
Diagnostic (68Ga-PSMA-11 PET/CT)ExperimentalPatients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

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

  1. Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)

    A separate analysis of initial versus subsequent management will be performed. Will be evaluated using descriptive statistics for both the treatment modality analysis and the disease stage based management analysis. Questionnaires will be collected to determine the intended patient management before and intended management changes after PET/CT, and to determine whether intended management changes were implemented. The outcome measure is the rate of change (%) as assessed by the questionnaires before and after PET.

    Measured: Up to 3-6 months after completion of imaging

Secondary outcomes (4)

  1. Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for biochemical progression-free survival (PFS)

    Measured: From inclusion to date until PSA progression or death (whichever occurs first), assessed up to 12 months

  2. Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for radiographic PFS

    Nodal and visceral disease will be evaluated on cross-sectional imaging using Response Evaluation Criteria in Solid Tumors 1.1/Prostate Cancer Working Group 3 (PCWG3) criteria. Bone metastases will be evaluated using bone scintigraphy and new lesions have to be confirmed on a second scan (2+2 rule) using PCWG3 criteria.

    Measured: From inclusion to date until first site of disease is found to progress or death (whichever occurs first), assessed up to 12 months

  3. Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for overall survival

    Measured: From inclusion to date of death, assessed up to 12 months

  4. Positive predictive value (PPV) on a per-patient and per-region basis of 68Ga-PSMA-11 PET for detection of tumor location

    Confirmed by histopathology/biopsy or follow-up assessed separately for initial staging and restaging. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method. PPV will be reported for each of the three blinded readers independently. Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate-specific antigen (PSA) value will be summarized in tabular format and compared between PSA strata using chi-square analysis. Detection rate is defined as number of patients with PSMA positive disease, independent of pathology, imaging or clinical follow-up. A detection rate will be reported for each reader independently stratified by PSA.

    Measured: Up to 12 months

Timeline

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

  1. First posted8 Aug 2019
  2. Study start2 Apr 2018
  3. Primary completion27 Sep 2021
  4. Study completion27 Sep 2021

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
937 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050215
Sponsor's protocol ID
17-001336
Other IDs
NCI-2019-04439
Status last verified
Sep 2021
First submitted
6 Aug 2019
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nikitas J, Smith CP, Armstrong WR, Murthy V, Grogan T, Clark K, Moore J, Roberts M, Farolfi A, Reiter RE, Rettig MB, Shen J, Valle LF, Nickols NG, Steinberg ML, Czernin J, Kishan AU, Calais J. Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy. J Natl Compr Canc Netw. 2026 Feb;24(2):11-18. doi: 10.6004/jnccn.2025.7102.

    PubMed 41698328

  • Ma TM, Gafita A, Shabsovich D, Juarez J, Grogan TR, Thin P, Armstrong W, Sonni I, Nguyen K, Lok V, Reiter RE, Rettig MB, Steinberg ML, Kupelian PA, Yang DD, Muralidhar V, Chu C, Feng F, Savjani R, Deng J, Parikh NR, Nickols NG, Elashoff D, Czernin J, Calais J, Kishan AU. Identifying the Best Candidates for Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography as the Primary Staging Approach Among Men with High-risk Prostate Cancer and Negative Conventional Imaging. Eur Urol Oncol. 2022 Feb;5(1):100-103. doi: 10.1016/j.euo.2021.01.006. Epub 2021 Feb 16.

    PubMed 33602654

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Gallium Ga 68-labeled PSMA-11 and Positron Emission Tomography in people with Biochemically Recurrent Prostate Carcinoma and Metastatic Prostate Carcinoma, 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 17 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: finished, as of the sponsor's last update on 30 Sep 2021. 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 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?

Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) (time frame: Up to 3-6 months after completion of imaging). 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 NCT04050215, 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 30 Sep 2021.

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