Trial Outcomes & Findings for PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study (NCT NCT04086966)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

1 scan

Results posted on

2024-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metastatic Prostate Cancer Arm n=10 Participants \[68Ga\]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
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=10 Participants
Age, Categorical >=65 years	8 Participants n=10 Participants
Sex: Female, Male Female	0 Participants n=10 Participants
Sex: Female, Male Male	10 Participants n=10 Participants
Region of Enrollment United States	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: 1 scan

Outcome measures

Outcome measures
Measure	Metastatic Prostate Cancer Arm n=10 Participants \[68Ga\]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
The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI	3 Participants

SECONDARY outcome

Timeframe: 1 scan

Outcome measures

Outcome measures
Measure	Metastatic Prostate Cancer Arm n=10 Participants \[68Ga\]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
The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI	19 lymph nodes

SECONDARY outcome

Timeframe: 1 simulation scan

Outcome measures

Outcome measures
Measure	Metastatic Prostate Cancer Arm n=10 Participants \[68Ga\]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
Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered	8 Participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Metastatic Prostate Cancer Arm n=10 Participants \[68Ga\]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
Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities	0 Participants

SECONDARY outcome

Timeframe: 1 scan

Outcome measures

Outcome measures
Measure	Metastatic Prostate Cancer Arm n=10 Participants \[68Ga\]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
The Total Number of Pelvic Nodal Metastases Detected on MRI	9 lymph nodes

Adverse Events

Metastatic Prostate Cancer Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

April Riddle

University of Alabama at Birmingham

Phone: (205)934-6504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place