PSMA PET Imaging of Recurrent Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-26

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.

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Detailed Description

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Conditions

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Prostate Adenocarcinoma Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ga-HBED-iPSMA PET with CT or MRI

Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.

Group Type ACTIVE_COMPARATOR

Ga-HBED-iPSMA PET

Intervention Type DRUG

Patients will be injected with 100-300 MBq of 68Ga-HBED-iPSMA and after a waiting of 60-90 minutes patients will be scanned from mid-skull to mid-thigh.

PET/CT

Intervention Type DIAGNOSTIC_TEST

PET/CT will be acquired using a GE 710 or 690 time-of-flight PET/CT scanner. Following a waiting period of 60-90 minutes post 68Ga-HBED-iPSMA administration, patients will be scanned from top of the skull to mid-thigh. Images will be acquired with patients in a supine position with their arms raised above their head. If patients cannot raise their arms above the head, the arms will be comfortably positioned and secured by the side of the patient. The PET may be combined with a CT scan as a PET/CT or a MRI scan as PET/MR.

MRI

Intervention Type DIAGNOSTIC_TEST

Patients may undergo a diagnostic MRI of the prostate, other body parts or a whole-body MRI at the same imaging session as clinically indicated.

Ga-HBED-iPSMA PET with MRI

Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.

Group Type ACTIVE_COMPARATOR

Ga-HBED-iPSMA PET

Intervention Type DRUG

Patients will be injected with 100-300 MBq of 68Ga-HBED-iPSMA and after a waiting of 60-90 minutes patients will be scanned from mid-skull to mid-thigh.

MRI

Intervention Type DIAGNOSTIC_TEST

Patients may undergo a diagnostic MRI of the prostate, other body parts or a whole-body MRI at the same imaging session as clinically indicated.

Interventions

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Ga-HBED-iPSMA PET

Patients will be injected with 100-300 MBq of 68Ga-HBED-iPSMA and after a waiting of 60-90 minutes patients will be scanned from mid-skull to mid-thigh.

Intervention Type DRUG

PET/CT

PET/CT will be acquired using a GE 710 or 690 time-of-flight PET/CT scanner. Following a waiting period of 60-90 minutes post 68Ga-HBED-iPSMA administration, patients will be scanned from top of the skull to mid-thigh. Images will be acquired with patients in a supine position with their arms raised above their head. If patients cannot raise their arms above the head, the arms will be comfortably positioned and secured by the side of the patient. The PET may be combined with a CT scan as a PET/CT or a MRI scan as PET/MR.

Intervention Type DIAGNOSTIC_TEST

MRI

Patients may undergo a diagnostic MRI of the prostate, other body parts or a whole-body MRI at the same imaging session as clinically indicated.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven adenocarcinoma of the prostate
* Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)
* For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy:

* PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients
* Note: The most recent PSA value must be within 6 weeks of consent
* For patients who have received additional treatment in the recurrent or metastatic setting:

° PSA ≥ 2 ng/ml above the most recent therapy nadir
* Age ≥ 18 years
* Patient must be able to tolerate PET/CT or PET/MR imaging