Clinical trial NCT04928820: 68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy
Official title: Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT With 99mTc-MDP Bone Scan and CT for Detection of M1b Disease in Prostate Cancer Patients With Biochemical Progression During ADT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Biochemically Recurrent Prostate Carcinoma
Metastatic Malignant Neoplasm in the Bone
Metastatic Prostate Carcinoma
Stage IV Prostate Cancer American Joint Committee on 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: 2021-06-16
Enrollment: 22
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 how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

Detailed description: PRIMARY OBJECTIVE:

I. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression.

SECONDARY OBJECTIVES:

I. To compare the number of lesions rated as positive for bone metastases between the two imaging tests.

II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c).

III. To compare the positive predictive value (PPV) per-patient in patients with lesion validation (follow-up imaging or biopsy).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT.

Eligibility criteria: Inclusion Criteria:

* Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen \[PSA\] level \>= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)
* Patients with bone scan scheduled or performed

  * Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between
  * Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized
* Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility
* Patients or their legal representatives must have the ability to read, understand and provide written informed consent

Exclusion Criteria:

* Initiation of a new therapy between the PSMA PET/CT and the bone scans
* Inability to provide written informed consent
* Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)

Primary outcomes:
measure: Per-patient detection rate of gallium Ga 68 gozetotide (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Number of lesions found by PSMA PET and bone scan + CT
timeFrame: Up to 4 years
measure: Rate of M1 detection
timeFrame: Up to 4 years
measure: Per-patient positive predictive value (PPV)
timeFrame: Up to 4 years
measure: PSA progression-free survival (PFS)
timeFrame: Up to 4 years
measure: Overall survival (OS)
timeFrame: Up to 4 years
measure: Incidence of adverse events
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Jeremie Calais, MD
role: PRINCIPAL_INVESTIGATOR
References: