Clinical trial · Observational
PSMA PET/CT for Assessment of Recurrent Prostate Cancer
Fluorine-18 - 2-(3-(1-carboxy-5-[(6-[18F]Fluoro-pyridine-3-carbonyl)-Amino]-Pentyl)-Ureido)-Pentanedioic Acid (18F-DCFPyL) Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent 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)
Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients will have their PC return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate-specific antigen (PSA) levels. This study proposes to use Fluorine-18-2-(3-(1-carboxy-5-\[(6-\[18F\]fluoro-pyridine-3-carbonyl)-amino\]-pentyl)-ureido)-pentanedioic acid (18F-DCFPyL) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the PC has recurred.
Conditions
Conditions (2)
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 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA PET/CT scan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- superiority of 18F-DCFPyL PET/CT over conventional imaging for detection of recurrent prostate cancer.
- timeFrame
- 3 years after the PSMA PET scan
- description
- Comparison to conventional imaging studies, pathology and clinical follow-up up to 3 years after PSMA imaging.
Secondary outcomes (1)
- measure
- clinical impact of 18F-DCFPyL PET/CT
- timeFrame
- 6 months after the PSMA PET scan
- description
- To assess the clinical impact of 18F-DCFPyL scans inpatient management. Eg, surgical resection or localized radiation.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Known PC with a biochemical recurrence (BR) after initial curative therapy with radical prostatectomy, with a documented history of failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increased on 2 or more determinations (PSA recurrence). The patient may have received treatment following documentation of PSA persistence or PSA recurrence. The most recent PSA measurement must be greater than 0.4 ng/mL. * Participants with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease. * Known PC with BR after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level \>2 ng/mL above the nadir after radiation therapy. * Castration resistant PC with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (\<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan. * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. Exclusion Criteria: * Medically unstable (eg. acute illness, unstable vital signs) * Unable to lie supine for the duration of imaging * Unable to provide written consent * Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
References
Publications (2)
- DERIVEDHarsini S, Martineau P, Plaha S, Saprunoff H, Chen C, Bishop J, Tyldesley S, Wilson D, Benard F. Prognostic significance of a negative PSMA PET/CT in biochemical recurrence of prostate cancer. Cancer Imaging. 2024 Aug 30;24(1):117. doi: 10.1186/s40644-024-00752-1. PMID 39210431
- DERIVEDHarsini S, Wilson D, Saprunoff H, Allan H, Gleave M, Goldenberg L, Chi KN, Kim-Sing C, Tyldesley S, Benard F. Outcome of patients with biochemical recurrence of prostate cancer after PSMA PET/CT-directed radiotherapy or surgery without systemic therapy. Cancer Imaging. 2023 Mar 17;23(1):27. doi: 10.1186/s40644-023-00543-0. PMID 36932416