Metastatic Prostate Cancer
Conditions
Brief summary
This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.
Interventions
DRUG[68Ga]PSMA-PET/MRI or PET/CT
\[68Ga\]PSMA-PET/MRI or PET/CT
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy-proven treatment-naïve prostate adenocarcinoma with pelvic metastases known to suspected on standard-of-care staging imaging * Eligibility and plan to undergo definitive radiation therapy for prostate cancer per established standard-of-care radiation oncology clinical guidelines * Be at least 18 years of age
Exclusion criteria
* Inability to tolerate or undergo PET/MRI or PET/CT * Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.) * Recurrent prostate adenocarcinoma * Known distant metastatic disease * Current or prior treatment for prostate cancer * Known allergy to glucagon * Previous diagnosis of insulinoma or pheochromocytoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI | 1 scan |
Secondary
| Measure | Time frame |
|---|---|
| The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI | 1 scan |
| Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered | 1 simulation scan |
| Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities | 18 months |
| The Total Number of Pelvic Nodal Metastases Detected on MRI | 1 scan |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metastatic Prostate Cancer Arm \[68Ga\]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer
\[68Ga\]PSMA-PET/MRI or PET/CT: \[68Ga\]PSMA-PET/MRI or PET/CT | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Metastatic Prostate Cancer Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI
Time frame: 1 scan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metastatic Prostate Cancer Arm | The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI | 3 Participants |
Secondary
Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered
Time frame: 1 simulation scan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metastatic Prostate Cancer Arm | Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered | 8 Participants |
Secondary
Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metastatic Prostate Cancer Arm | Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities | 0 Participants |
Secondary
The Total Number of Pelvic Nodal Metastases Detected on MRI
Time frame: 1 scan
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metastatic Prostate Cancer Arm | The Total Number of Pelvic Nodal Metastases Detected on MRI | 9 lymph nodes |
Secondary
The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI
Time frame: 1 scan
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metastatic Prostate Cancer Arm | The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI | 19 lymph nodes |