Clinical trial · Expanded Access
Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer
68Ga PSMA-11 in Patients With Intermediate to High-risk Prostate Cancer Before Prostatectomy or With Biochemical Recurrence of Prostate Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.
Conditions
Conditions (5)
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 Recurrent | — | UNRESOLVED | — |
| Prostatic Diseases | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68GA PSMA-HBED-CC | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: PLANNED PROSTATECTOMY * Biopsy-proven prostate adenocarcinoma * Intermediate to high-risk disease, defined as one of the following factors: PSA \> 10, T2b or greater, or a Gleason score of 7 or greater. * Planned prostatectomy with lymph node dissection * Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu) BIOCHEMICAL RECURRENCE * Pathologically proven prostate adenocarcinoma. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). * If post-radical prostatectomy, PSA \> 0.2 ng/mL measured \> 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (AUA recommendation for biochemical recurrence). * If post-radiation therapy, PSA that is equal to or greater than a 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence). * No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion). ALL * Karnofsky performance status (KPS) \>= 50 (ECOG/WHO 0, 1, or 2) * Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations * Ability to understand and the willingness to provide informed consent Exclusion Criteria: * History of Stevens-Johnson syndrome * Known Paget's disease * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (0)
Data not yet available