[68Ga]Ga-PSMA-11 PET/CT in the Assessment of High Risk and Recurrent Prostate Cancer

NCT04484701 | Active Not Recruiting

• 1 other identifier: H20-01325
• Study Type: observational
• Target: 1,574
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate specific antigen levels. This study proposes to use Gallium-68-PSMA-11 (68Ga-PSMA-11) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the prostate cancer has recurred.

Conditions

Prostatic Neoplasm; Prostatic Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity of 68Ga-PSMA-11 PET/CT imaging in the assessment of high risk and recurrent prostate cancer.

  Determination of sensitivity when compared with pathology reports (if available) and routine imaging (CT, MRI, bone scan) if available.

  5 years after PSMA-11 PET/CT scan

Secondary Outcomes (4)

• Predictive value of 68Ga-PSMA-11 PET/CT imaging

  5 years after the PSMA PET scan

• Accuracy of 68Ga-PSMA-11 PET/CT imaging

  5 years after the PSMA PET scan

• Specificity of 68Ga-PSMA-11 PET/CT imaging

  5 years after the PSMA PET scan

• Number of participants with self-reported 68Ga-PSMA-11-related adverse event

  12 hours post 68Ga-PSMA-11 injection

Study Arms (1)

PSMA-11 PET/CT scan

All participants will undergo the same procedures listed in "Detailed Description" in the protocol section.

Drug: 68Ga-PSMA-11

Interventions

68Ga-PSMA-11 DRUG

PET/CT scan with radiotracer 68Ga-PSMA-11

PSMA-11 PET/CT scan

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with high risk prostate cancer at initial presentation (CAPRA score 6 or higher), subjects with biochemical persistence of prostate cancer following radical prostatectomy, subjects with biochemical recurrence of prostate cancer following initial curative treatment with radical prostatectomy or radiation therapy, subjects with biochemical recurrence of prostate cancer following radical prostatectomy who received subsequent salvage radiotherapy, and subjects with advanced prostate cancer (castration sensitive or castration resistant disease that is metastatic with conventional imaging, castration resistant disease that is non-metastatic on conventional imaging).

You may qualify if:

• Eastern Cooperative Oncology Group performance status of 2 or less.
• Subjects with high risk prostate cancer (CAPRA score 6 or higher) being considered for curative-intent surgery or radiation therapy (including brachytherapy)
• Subjects with biopsy confirmed prostate cancer being considered for curative-intent surgery or radiation therapy (including brachytherapy), who have unconfirmed suspicious findings on conventional medical imaging staging examinations.
• Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy, with two consecutive PSA values \>0.2 ng/ml measured more than 6 weeks after radical prostatectomy. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL.
• Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy and subsequently treated by salvage radiotherapy or pelvic node dissection, with two consecutive PSA values \>0.2 ng/ml. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL.
• Subjects with biochemical recurrence of prostate cancer after initial curative therapy with radiation therapy (including brachytherapy), or non-standard local ablative therapy (such as high frequency ultrasound, cryoablation, focal laser ablation, etc.), with a PSA level \>2 ng/mL above the nadir after radiation therapy.
• Subjects with advanced castration sensitive or castration resistant prostate cancer being considered for localized treatment (surgery, brachytherapy, radiotherapy) of recurrent or oligometastatic prostate cancer. Castration resistance is defined as a PSA level \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L).
• Subjects with metastatic or castration resistant prostate cancer being evaluated for systemic therapy administered in therapeutic clinical trials. The PSA level must be \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L).

You may not qualify if:

• Medically unstable (e.g. acute illness, unstable vital signs)
• Unable to lie supine for the duration of imaging
• Unable to provide written consent
• Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
• Subjects with end stage renal disease.
• Subjects with documented history of severe progressive chronic kidney disease (glomerular filtration rate less than 30 mL/min/1.73 m2).
• Subjects with hypersensitivity to furosemide (Lasix).
• While cross-reactivity between sulfonamide antibiotics and non-antibiotics has been disproven, subjects who have a history of sulfonamide antibiotics or sulfonylureas may be at a higher risk of allergic reaction to furosemide due to a higher general predisposition to allergic reactions. In those instances, the administration of furosemide is left at the discretion of the local site investigator after discussion with the study subject.
• Subjects with severe hypokalemia, hyponatremia, hypovolemia, dehydration or hypotension.
• Subjects with untreated bladder outlet obstruction or lower urinary tract symptoms, who have a history of obstructive episodes that required hospitalization, emergency department visits and/or bladder catheterization for relief of symptoms.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Francois Benard, MD

  BC Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: February 1, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)