Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy (PREDICT-Study)

Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy (PREDICT-Study) - PREDICT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55216

Enrollment

284

Registered

2021-06-04

Start date

2021-07-01

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 prostate carcinoma

Interventions

Randomization will be performed to determine whether patients will be submitted to group 1 or 2. Patients in group 1 will undergo a radical prostatectomy with an ePLND. Patients in group 2 will unde

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male, aged >= 18 years - Prostate cancer patients with a Briganti calculated risk of LN metastases between 5-20% without evidence of metastases on PSMA PET/CT requiring an ePLND in the standard treatment - Scheduled for a (robot-assisted) laparoscopic radical prostatectomy - Written informed consent

Exclusion criteria

Exclusion criteria: - American Society of Anaesthesiology (ASA) classification > 3 - Patients with a contraindication for a lymphadenectomy - Neoadjuvant hormone deprivation therapy - Absence or withdrawal of an informed consent - Evidence of metastases on PSMA PET/CT

Design outcomes

Primary

Measure	Time frame
Persistent PSA rate 6 months after radical prostatectomy (persistent PSA is defined as a PSA value >= 0.1 ng/ml)	—

Secondary

Measure	Time frame
• Biochemical recurrence-free survival (BCR-FS) (BCR is defined as a PSA value >= 0.2 ng/ml). • Metastasis-free survival • Incidence of lymphoceles and complications six months after RP (using Clavien-Dindo classification) • Incidence of adjuvant therapy (androgen deprivation therapy, radiation therapy or salvage lymph node dissection) • Functional outcomes (quality of life, continence, potency)	—

Measure

Time frame

• Biochemical recurrence-free survival (BCR-FS) (BCR is defined as a PSA value >= 0.2 ng/ml). • Metastasis-free survival • Incidence of lymphoceles and complications six months after RP (using Clavien-Dindo classification) • Incidence of adjuvant therapy (androgen deprivation therapy, radiation therapy or salvage lymph node dissection) • Functional outcomes (quality of life, continence, potency)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)