Clinical trial NCT04483414: 68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
Official title: The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Cancer Metastatic
Prostate Cancer Metastatic to Bone
Keywords: PET/CT
prostate cancer
Gallium-68
PSMA-11
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Unblinded, single arm imaging study
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA) after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence.

This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer compared to conventional imaging. In addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.

Eligibility 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.

Primary outcomes:
measure: Location of recurrence
timeFrame: Up to 3 years
measure: Residual prostate cancer
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Orhan K Oz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: