Clinical trial · Interventional
Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer
Effects of Novel Androgen Receptor Signaling Inhibitors on PSMA PET Signal Intensity in Patients With Castrate-Resistant Prostate Cancer: A Prospective Exploratory Study
NCT04279561CI-TRIAL-00060972terminatedPhase 1ClinicalTrials.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 accrual
Summary
Brief summary (as posted)
This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.
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 |
|---|---|---|---|
| Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| 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 | Drug | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (68GA-PSMA-11 PET/CT)
- description
- Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
- interventionNames
- Procedure: Computed Tomography
- Drug: Gallium Ga 68 Gozetotide
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Changes in 68Ga-PSMA-11 lesion and total-body uptake (standardized uptake value [SUV]max and SUVmean) over time in response to androgen receptor signaling inhibitors (ARSI)
- timeFrame
- Baseline, assessed up to 1 year
- description
- Changes are expressed in terms of percentage changes from baseline positron emission tomography (PET) (before ARSI). Will utilize mixed effect regression models to evaluate the change over time in PSMA results.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer * Know metastatic disease on previous imaging, or PSA value ⩾ 1 ng/ml; * Castration resistant disease with confirmed testosterone level =\< 50 ng/ml under prior first-line androgen deprivation therapy (ADT) * New planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide * Willingness to undergo ARSI throughout the duration of the study as prescribed by the treating uro-oncologist * Stated willingness to comply with continuation of ARSI treatment for the duration of the study * Provision of signed and dated informed consent form Exclusion Criteria: * Inability to provide written informed consent * Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes) * Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy * A baseline superscan pattern on bone scan * Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible
References
Publications (2)
- DERIVEDNikitas J, Smith CP, Armstrong WR, Murthy V, Grogan T, Clark K, Moore J, Roberts M, Farolfi A, Reiter RE, Rettig MB, Shen J, Valle LF, Nickols NG, Steinberg ML, Czernin J, Kishan AU, Calais J. Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy. J Natl Compr Canc Netw. 2026 Feb;24(2):11-18. doi: 10.6004/jnccn.2025.7102. PMID 41698328
- DERIVEDSonni I, Gafita A, Unterrainer LM, Alano RM, Lira S, Shen J, Drakaki A, Grogan T, Rettig MB, Czernin J, Calais J. Effects of novel androgen receptor signaling inhibitors on PSMA PET signal intensity in patients with castrate-resistant prostate cancer: a prospective exploratory serial imaging study. EJNMMI Res. 2023 Oct 30;13(1):95. doi: 10.1186/s13550-023-01048-4. PMID 37902861