Clinical trial NCT04050215: 68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer
Official title: Impact of 68GA-PSMA-11 PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biochemically Recurrent Prostate Carcinoma
Metastatic Prostate Carcinoma
Prostate Adenocarcinoma
Prostate Carcinoma
PSA Level Greater Than Fifty
PSA Progression
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 937
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

I. 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.

Eligibility criteria: Inclusion Criteria:

* 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
    * 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
timeFrame: Up to 3-6 months after completion of imaging
Secondary outcomes:
measure: Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for biochemical progression-free survival (PFS)
timeFrame: From inclusion to date until PSA progression or death (whichever occurs first), assessed up to 12 months
measure: Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for radiographic PFS
timeFrame: From inclusion to date until first site of disease is found to progress or death (whichever occurs first), assessed up to 12 months
measure: Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for overall survival
timeFrame: From inclusion to date of death, assessed up to 12 months
measure: Positive predictive value (PPV) on a per-patient and per-region basis of 68Ga-PSMA-11 PET for detection of tumor location
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Jeremie Calais
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.