PSMA PET Imaging of Recurrent Prostate Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Adenocarcinoma; Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03204123

16-306

Details and patient eligibility

About

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.

Enrollment: 1,171 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,171 participants in 2 patient groups

Ga-HBED-iPSMA PET with CT or MRI

Active Comparator group

Description:

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.

Treatment:

Drug: Ga-HBED-iPSMA PET

Diagnostic Test: MRI

Diagnostic Test: PET/CT

Ga-HBED-iPSMA PET with MRI

Active Comparator group

Description:

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.

Treatment:

Drug: Ga-HBED-iPSMA PET

Diagnostic Test: MRI