68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess treatment response to subsequent salvage therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana Mathews
• Treatments: Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• Patients with suspected BCR of prostate cancer following initial treatment with either prostatectomy or definitive EBRT of the prostate or patients with known metastatic prostate cancer who have failed systemic therapy.

• Patients being considered for salvage therapy.

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.

• Patients must be medically stable as judged by the patient's physician.

• Patients must be able to lie still for 20-40 minutes for the PET/CT scans.

• Ability to understand and the willingness to sign a written informed consent.

• Patients with BCR and no known lesions should not be on antiandrogen therapy at the time of scans. Patients with known metastases who are currently being treated with anti-androgen therapy may remain on this medication.

Exclusion Criteria:

• Patients who have or have had a biopsy proven concurrent other malignancy, excluding skin cancers.

• Patients may not weigh more than the maximum weight limit for the PET /CT scanner table (> 200 kg or 440 pounds).

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. Furosemide will not be administered to patients with known allergy.

• Patients must not be claustrophobic.