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Completed

NCT Number: NCT02673151

68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

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Key information

Conditions

Prostate Adenocarcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site PSA Failure Prostatic Diseases Prostatic Neoplasms Recurrent Prostate Carcinoma Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

About this study

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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) - American Urology Association (AUA) recommendation
  • PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
  • Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
  • Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition
  • A rise of PSA measurement of 2 or more ng/mL over the nadir
  • Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group [ECOG] / World Health Organization [WHO] equivalent)
  • Able to provide written consent

Exclusion criteria

  • Investigational therapy for prostate cancer.
  • Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan.
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Treatment and study plan

Computed Tomography (CT) Scan

Procedure

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Other names: Computerized Axial Tomography (CAT), CAT scan, Computed Tomography (CT), Computerized Tomography (CT), CT Scan, tomography

68Ga-PSMA-11

Drug

68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.

Other names: 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-HBED-CC-PSMA, HBED-CC-PSMA, DFKZ-11, Heidelberg compound

Positron Emission Tomography (PET)

Procedure

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Other names: Positron Emission Tomography scan (PET-scan), Proton magnetic resonance spectroscopic imaging

Primary outcomes

  1. Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT

    Time frame: up to 12 months

    Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.

Secondary outcomes

  1. 68Ga-PSMA-11 PET/CT Sensitivity and Specificity

    Time frame: up to 12 months

    68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.

  2. 68Ga-PSMA-11 PET/CT Predictive Value by Region

    Time frame: up to 12 months

    Positive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.

  3. Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level

    Time frame: up to 12 months

    Scan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows.

    • 0.2 to < 0.5
    • 0.5 to < 1.0
    • 1.0 to < 2.0
    • 2.0 to < 5.0
    • ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.

Sponsors and collaborators

Lead sponsor

Andrei Iagaru

Other

Registry information

Official study title

68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 3, 2016
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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