Prostatic Artery Injection vs Intra-Venous Injectin of 18F-DCFPyL to evaluate treatment strategy in Prostate cancer

Prostatic Artery Injection vs Intra-Venous Injectin of 18F-DCFPyL to evaluate treatment strategy in Prostate cancer - PAI vs IV injection of 18F-DCFPyL PET/CT in Prostate Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49732

Enrollment

Registered

2020-12-29

Start date

2021-12-15

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

For this study a catheter directed angiography of the prostate arteries will be performed in each patient. Direct arterial administration of radiotracer into the vascular bed of the prostate gland v

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >70 years • Confirmed histological diagnosis of PCa • All (T) (N) (M) stages • The Eastern Cooperative Oncology Group (ECOG) performance status = 1500 cells/µL o Platelet count >= 100.000/µL o Hemoglobin >= 5.6 mmol/L o AST and ALT = 40 mL/min for subject with creatinine levels. • Signed Informed Consent Form

Exclusion criteria

Exclusion criteria: • History of concomitant malignancies • Severe allergy for iodine-based contrast agents • Prior treatments with brachytherapy or prostatectomy • Inability to undergo intra-arterial procedure secondary to vascular abnormalities • Body weight over 150 kg • Severe allergy for I.V. contrast used in angiography

Design outcomes

Primary

Measure	Time frame
• Increase the ratio target (prostate cancer lesion) vs. non-target to background (gluteal muscle and blood pool) accumulation by 30% with intra-arterial compared to systemic administration evaluated on PET/CT images using SUV(mean and/ or max)	—

Secondary

Measure	Time frame
• Lower the ratio target vs. non-target tissue accumulation, especially to the kidneys and salivary glands, by 30% compared to systemic administration evaluated via the radiation measured on PET/CT images SUV(mean and/ or max). • Detection of new lesions in the primary prostate tumor within the prostate gland or local lymph node identification / micro metastasis after local administration compared to standard of care systemic administration • Registration on the number and severity of adverse events (AEs, SAEs and SUSARs) with intra-arterial compared to systemic administration • Evaluation of accumulation patterns on PET/CT in the prostate bed after intra-arterial compared to systemic administration derived by image-based heterogeneity parameters. • Estimation of 177Lu-PSMA radiation dose using 18F-DCFPyL accumulation patterns on PET/CT after intra-arterial vs. systemic administration.	—

Measure

Time frame

• Lower the ratio target vs. non-target tissue accumulation, especially to the kidneys and salivary glands, by 30% compared to systemic administration evaluated via the radiation measured on PET/CT images SUV(mean and/ or max). • Detection of new lesions in the primary prostate tumor within the prostate gland or local lymph node identification / micro metastasis after local administration compared to standard of care systemic administration • Registration on the number and severity of adverse events (AEs, SAEs and SUSARs) with intra-arterial compared to systemic administration • Evaluation of accumulation patterns on PET/CT in the prostate bed after intra-arterial compared to systemic administration derived by image-based heterogeneity parameters. • Estimation of 177Lu-PSMA radiation dose using 18F-DCFPyL accumulation patterns on PET/CT after intra-arterial vs. systemic administration.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)