Clinical trial · Interventional
68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was closed since no participants were enrolled.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
| Prostate Cancer Metastatic to Bone | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga PSMA-11 injection | Drug | — | UNRESOLVED |
| Positron Emission Tomography/Computed Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with suspected BCR or metastatic prostate cancer
- description
- Patients with suspected BCR or metastatic prostate cancer
- interventionNames
- Drug: 68Ga PSMA-11 injection
- Procedure: Positron Emission Tomography/Computed Tomography
Primary outcomes (2)
- measure
- Location of recurrence
- timeFrame
- Up to 3 years
- description
- Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
- measure
- Residual prostate cancer
- timeFrame
- Up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available