Clinical trial · Interventional
68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy
Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT With 99mTc-MDP Bone Scan and CT for Detection of M1b Disease in Prostate Cancer Patients With Biochemical Progression During ADT
NCT04928820CI-TRIAL-00061609terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow recruitment
Summary
Brief summary (as posted)
This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biochemically Recurrent Prostate Carcinoma | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Bone | — | UNRESOLVED | — |
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Gallium Ga 68 Gozetotide | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (68Ga-PSMA-11 PET/CT)
- description
- Patients receive gallium Ga 68 gozetotide IV. After 50-100 minutes, patients undergo whole body PET/CT.
- interventionNames
- Procedure: Computed Tomography
- Other: Gallium Ga 68 Gozetotide
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Per-patient detection rate of gallium Ga 68 gozetotide (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
- timeFrame
- Up to 4 years
- description
- 68Ga-PSMA-11 PET will be compared to bone scan/CT for M1b disease in prostate cancer patients progressing during androgen deprivation therapy. Patients who have at least one positive bone lesion will be rated positive. Patients will be treated as binary categorization. The analysis of the primary objective will utilize the McNemar's test to compare the detection rate between the imaging techniques.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen \[PSA\] level \>= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart) * Patients with bone scan scheduled or performed * Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between * Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized * Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility * Patients or their legal representatives must have the ability to read, understand and provide written informed consent Exclusion Criteria: * Initiation of a new therapy between the PSMA PET/CT and the bone scans * Inability to provide written informed consent * Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
References
Publications (1)
- DERIVEDNikitas J, Gafita A, Benz MR, Djaileb L, Farolfi A, Hotta M, Sonni I, Alano R, Rettig M, Shen J, Armstrong W, Grogan T, Liu S, Czernin J, Calais J. Phase 2 trial of PSMA PET CT versus planar bone scan and CT in prostate cancer patients progressing while on androgen deprivation therapy. Sci Rep. 2024 Oct 18;14(1):24411. doi: 10.1038/s41598-024-75589-6. PMID 39420060