Clinical trial · Interventional
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer
NCT00928252CI-TRIAL-00029057completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide information that may help guide subsequent investigational or clinical treatments for patients with advanced (hormone-refractory) metastatic prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IV fluorine-18 labeled methylcholine before PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Received 18F-fluorocholine PET/CT
- description
- IV fluorine-18 labeled methylcholine before PET/CT
- interventionNames
- Drug: IV fluorine-18 labeled methylcholine before PET/CT
Primary outcomes (3)
- measure
- Metabolically Active Tumor Volume (MATV) Response
- timeFrame
- 21 to 98 days
- description
- Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT
- measure
- Time to PSA Progression
- timeFrame
- 2 years
- description
- Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of written informed consent. 2. Men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer 3. History of treatment by complete androgen blockade for greater than 3 months prior to enrollment 4. Progressive disease evidenced by 2 consecutive rises in PSA measured at least 1 week apart, with the absolute value of the latest PSA \> 5.0 ng/ml. 5. A rise in PSA following anti-androgen drug withdrawal, above the last PSA value before withdrawal. 6. Patient has agreed to treatment for hormone-refractory (ie. castrate-resistant) prostate cancer under supervision of a medical oncologist, urologist, radiation oncologist or nuclear medicine physician. Treatments indicated for HRPC are docetaxel-, cabazitaxel-, or mitoxantrone-based chemotherapy, abiraterone, radium-223, enzalutamide, or sipulecuil-T. Exclusion Criteria: 1. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder. 2. Serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging. 3. Patient weighs over 350 lbs (due to scanner weight limit). 4. Clinical life expectancy \< 12 weeks. 5. Participated in other radioactive drug studies where estimated total cumulative dose within 1 year is \> 0.05 Sievert for whole body, active blood-forming organs, eye lens, gonads, or 0.15 Sievert for other organs. 6. Concurrent Therapy. Allowed: Prior or concurrent chemotherapy, but must be \> 12 weeks since last treatment at enrollment; prior or concurrent hormonal therapy; prior surgery; prior or concurrent bisphosphonate; prior or concurrent receptor/biologic agent allowed if given on approved study protocol.
References
Publications (1)
- DERIVEDLee J, Sato MM, Coel MN, Lee KH, Kwee SA. Prediction of PSA Progression in Castration-Resistant Prostate Cancer Based on Treatment-Associated Change in Tumor Burden Quantified by 18F-Fluorocholine PET/CT. J Nucl Med. 2016 Jul;57(7):1058-64. doi: 10.2967/jnumed.115.169177. Epub 2016 Feb 16. PMID 26912444