Gallium-68 PSMA-11 PET/CT for the Diagnosis of Biochemically Recurrent Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:

Gallium-68 PSMA-11 and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144010
• Other study ID #: MC1952
• Secondary ID: NCI-2019-07001MC
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies how well gallium-68 PSMA-11 PET/CT works for the diagnosis of prostate cancer with rising PSA following prostatectomy or radiation therapy (biochemically recurrent). Gallium-68 PSMA-11 is a radioactive tracer. PET/CT scans reveal information about both the structure and function of cells and tissues in the body during a single imaging session using a radioactive compound. This trial is being done to see if gallium-68 PSMA-11 PET/CT scan works better in diagnosing prostate cancer compared to standard C-11 choline PET/CT scans.

Description:

PRIMARY OBJECTIVE:

I. Positive predictive value (PPV) on a per-patient basis of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) and carbon C 11 choline (C-11 choline) positron emission tomography (PET) for detection of tumor location confirmed by histopathology/biopsy.

SECONDARY OBJECTIVES:

I. PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 and C-11 choline PET for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.

II. Sensitivity and specificity on a per-patient and per-region basis of 68Ga-PSMA-11 and C-11 choline PET for detection of tumor location confirmed by histopathology/biopsy and/or conventional imaging follow-up.

III. Detection rates on a per-patient basis of 68Ga-PSMA-11 and C-11 choline PET stratified by prostate specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, > 5.0).

IV. Impact of 68Ga-PSMA-11 and C-11 choline PET on clinical management in BCR patients.

V. Inter-reader reproducibility. VI. Safety of 68Ga-PSMA-11, as characterized by Common Terminology Criteria for Adverse Events (CTCAE) 4.03.

OUTLINE:

Patients receive 68Ga-PSMA-11 and C-11 choline intravenously (IV) and then undergo PET/computed tomography (CT) imaging over 30 minutes.

After completion of study, patients are followed up at 1-3 days and then for 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histopathological proven prostate adenocarcinoma

• Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam and/or brachytherapy) or prostate cancer ablation

• Post radical prostatectomy (RP) ? with or without radiation

• PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP

• > 3 months post-surgery

• Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition

• May or may not be castrate resistant (list prior therapies, i.e. androgen deprivation therapies)

• Post-prostate cancer tissue ablation

• In patients post-ablation for primary prostate cancer treatment, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after ablation

• > 3 months post-prostate bed ablation

• In patients with intact prostate, per ASTRO-Phoenix consensus definition

• Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

• CT as part of the PET study or performed within 30 days of PSMA PET

• Ability to understand a written informed consent document, and the willingness to sign it

• Total testosterone test measured within 30 days of PSMA PET

Exclusion Criteria:

• Undergoing (or within 4 months) investigational therapy for prostate cancer

• Other ongoing (or within 4 months) treatments for prostate cancer including radiation therapy or chemotherapy

• Unable to lie flat, still or tolerate a 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

• Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device)

• Absence of PSA and total testosterone tests within 30 days

Related Conditions & MeSH terms

• Adenocarcinoma
• Biochemically Recurrent Prostate Carcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• PSA Failure
• PSA Progression

Intervention

Combination Product:
• Carbon C 11 Choline
Given IV

Procedure:
• Computed Tomography
Undergo PET/CT imaging

Other:
• Gallium Ga 68-labeled PSMA-11
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT imaging

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor detection on positron emission tomography (PET)/computed tomography (CT)	Positive predictive value on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) and carbon C 11 choline (C-11 choline) PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.	12 months post PET/CT
Secondary	Impact of Ga68-PSMA11 and C-11 choline PET on clinical management	Descriptive statistics will be used to evaluate the impact of Ga68-PSMA11 and C-11 choline PET on clinical management.	12 months
Secondary	Incidence of adverse events attributable to Ga68-PSMA11	Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0).	12 months