PSMA PET Imaging of Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

PSMA PET Imaging of Recurrent Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03204123
• Other study ID #: 16-306
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 26, 2017
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1171
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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.

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Consent only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent only )	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease localization by PSMA PET/MR		2 years
Secondary	PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT		2 years
Secondary	Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)	The safety and tolerability of 68Ga-HBED-iPSMA will be followed by assessing the incidence, nature and severity of toxicities by common terminology criteria for adverse events (CTCAE v4.0)	2 years

External Links

•   Memorial Sloan Kettering Cancer Center