PSMA PET Imaging of Recurrent Prostate Cancer

NCT03204123 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 16-306
• Study Type: interventional
• Target: 1,171
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Prostate Adenocarcinoma; Prostate Cancer

Keywords

prostate cancer; prostatectomy; biochemical recurrence; Ga-HBED-iPSMA; 16-306

Outcome Measures

Primary Outcomes (1)

• Disease localization by PSMA PET/MR

  2 years

Secondary Outcomes (2)

• PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT

  2 years

• Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)

  2 years

Study Arms (2)

Ga-HBED-iPSMA PET with CT or MRI

ACTIVE COMPARATOR

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.

Drug: Ga-HBED-iPSMA PET; Diagnostic Test: PET/CT; Diagnostic Test: MRI

Ga-HBED-iPSMA PET with MRI

ACTIVE COMPARATOR

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.

Drug: Ga-HBED-iPSMA PET; Diagnostic Test: MRI

Interventions

Ga-HBED-iPSMA PET 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.

Ga-HBED-iPSMA PET with CT or MRI; Ga-HBED-iPSMA PET with MRI

PET/CT 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.

Ga-HBED-iPSMA PET with CT or MRI

MRI 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 CT or MRI; Ga-HBED-iPSMA PET with MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Heiko Schöder, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: June 26, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

US (7)