Prostatic Neoplasm Clinical Trial
Official title:
68Ga-PSMA-11 Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of High Risk or Recurrent Prostate Cancer
NCT number | NCT04484701 |
Other study ID # | H20-01325 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2021 |
Est. completion date | September 2028 |
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.
Status | Recruiting |
Enrollment | 1574 |
Est. completion date | September 2028 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 19 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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) Exclusion criteria for the use of furosemide Subjects can still participate in the research study and undergo the [68Ga]Ga-PSMA-11 scan if they are unable or unwilling to receive a furosemide injection. - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | BC Cancer | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Predictive value of 68Ga-PSMA-11 PET/CT imaging | The clinical predictive value will be assessed by multivariate analysis, using a Cox proportional hazard model, including established clinical parameters at initial presentation or relapse for the 5 most active lesions. | 5 years after the PSMA PET scan | |
Secondary | Accuracy of 68Ga-PSMA-11 PET/CT imaging | The accuracy (along with the confidence interval) of 68Ga-PSMA-11 will be calculated for subjects with an available gold standard.
The gold standard for the detection of lesions will be established through a combination of: 1) pathology results following surgical resection; 2) disease progression of specific 68Ga-PSMA-11 findings on clinical or conventional imaging follow-up; 3) unequivocal disease response of specific 68Ga-PSMA-11 findings on conventional imaging follow-up after treatment; 4) decrease of PSA level after targeted radiation of 68Ga-PSMA-11 findings; 5) progression of 68Ga-PSMA-11 findings on subsequent 68Ga-PSMA-11 imaging associated with a concurrent increase in PSA level; 6) regression of [68Ga]Ga-PSMA-11 findings on subsequent [68Ga]Ga-PSMA-11 imaging associated with a concurrent decrease in PSA level. |
5 years after the PSMA PET scan | |
Secondary | Specificity of 68Ga-PSMA-11 PET/CT imaging | The specificity (along with the confidence interval) of [68Ga]Ga-PSMA-11 will be calculated for subjects with an available gold standard (see above for definition). | 5 years after the PSMA PET scan | |
Secondary | Number of participants with self-reported 68Ga-PSMA-11-related adverse event | Patients will be contacted by phone the day after the 68Ga-PSMA-11 PET/CT scan to see if they experienced any adverse events in the 12 hours following the 68Ga-PSMA-11 injection. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report. | 12 hours post 68Ga-PSMA-11 injection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Recruiting |
NCT05667636 -
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP
|
Phase 2 | |
Terminated |
NCT01996696 -
Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
|
Phase 2 | |
Completed |
NCT01431391 -
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
|
Phase 2 | |
Completed |
NCT03289130 -
Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness
|
||
Recruiting |
NCT04462926 -
Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed
|
N/A | |
Completed |
NCT00001446 -
A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
|
Phase 2 | |
Completed |
NCT02729103 -
Treatment Patterns in Metastatic Prostate Cancer
|
N/A | |
Completed |
NCT00956228 -
Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00126854 -
High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation
|
N/A | |
Completed |
NCT00247312 -
Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
|
Phase 3 | |
Completed |
NCT00174863 -
Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer
|
Phase 2 | |
Terminated |
NCT04221828 -
Trial of NanoPac Focal Therapy for Prostate Cancer
|
Phase 2 | |
Completed |
NCT00001266 -
A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT03935282 -
Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
|
N/A | |
Completed |
NCT03693742 -
MSG Use With 18F-DCFPyL PET/CT Imaging
|
N/A | |
Recruiting |
NCT06236789 -
Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
|
||
Completed |
NCT02966535 -
The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
|
N/A | |
Completed |
NCT02977143 -
Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery
|
N/A | |
Completed |
NCT00252460 -
CT/MRI Co-registration Prostate Cancer
|
Phase 1 |