68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2015 |
| End Date: | November 2020 |
68Ga-RM2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-contributory CT Scans
This phase II/III trial studies how well gallium (Ga) 68-labeled gastrin-releasing peptide
receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/magnetic
resonance imaging (MRI) works in detecting prostate cancer in patients with negative
computed tomography (CT) scan and elevated prostate-specific antigen levels after treatment
with surgery or radiation. PET/MRI scans take both PET and MRI images at the same time and
combine them into a single picture and is used to describe information regarding the
function, as well as location and size of a tumor. 68Ga-RM2, a compound made of a
radioactive agent linked to a pharmacological substance that is strongly attracted by a
substance made by tumor cells, to detect prostate cancer. 68Ga-RM2 PET/MRI may be able to
see smaller tumors than the standard of care contrast-enhanced CT or MRI scan
receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/magnetic
resonance imaging (MRI) works in detecting prostate cancer in patients with negative
computed tomography (CT) scan and elevated prostate-specific antigen levels after treatment
with surgery or radiation. PET/MRI scans take both PET and MRI images at the same time and
combine them into a single picture and is used to describe information regarding the
function, as well as location and size of a tumor. 68Ga-RM2, a compound made of a
radioactive agent linked to a pharmacological substance that is strongly attracted by a
substance made by tumor cells, to detect prostate cancer. 68Ga-RM2 PET/MRI may be able to
see smaller tumors than the standard of care contrast-enhanced CT or MRI scan
PRIMARY OBJECTIVES:
I. To evaluate 68Ga-RM2 (formerly known as DOTA bombesin or BAY 86-7548) PET/MRI for
detection of recurrent prostate cancer after initial therapy in patients with elevated
prostate-specific antigen (PSA) and non-contributory computed tomography (CT).
OUTLINE:
Patients receive 68Ga-RM2 intravenously (IV) and beginning 45 minutes later undergoing
PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to
evaluate response to therapy, if requested by the treating physician.
After completion of study, patients are followed up at 24-48 hours and then at 1 year.
I. To evaluate 68Ga-RM2 (formerly known as DOTA bombesin or BAY 86-7548) PET/MRI for
detection of recurrent prostate cancer after initial therapy in patients with elevated
prostate-specific antigen (PSA) and non-contributory computed tomography (CT).
OUTLINE:
Patients receive 68Ga-RM2 intravenously (IV) and beginning 45 minutes later undergoing
PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to
evaluate response to therapy, if requested by the treating physician.
After completion of study, patients are followed up at 24-48 hours and then at 1 year.
Inclusion Criteria:
- Biopsy proven prostate adenocarcinoma
- Rising PSA after definitive therapy with prostatectomy or radiation therapy (external
beam or brachytherapy
- Post radical prostatectomy (RP) - American Urological Association (AUA)
recommendation
- PSA greater than 0.2 ng/mL measured 6-13 weeks after RP
- Confirmatory persistent PSA greater than 0.2 ng/mL
- Post-radiation therapy - American Society for Therapeutic Radiology and Oncology
(ASTRO)-Phoenix consensus definition
- Nadir plus (+) greater than or equal to 2 ng/mL rise in PSA
- No evidence of metastatic disease on conventional imaging, including a negative bone
scan for skeletal metastasis and negative contrast-enhanced CT
- Able to provide written consent
- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
[ECOG]/World Health Organization [WHO] equivalent)
Exclusion Criteria:
- Unable to provide informed consent
- Inability to lie still for the entire imaging time
- 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 intercurrent illness, or other extenuating
circumstance that, in the opinion of the investigator, may significantly interfere
with study compliance
- Metallic implants
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Andrei Iagaru
Phone: 650-736-8965
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