Prospective randomized trial to evaluate the prognostic role of lymphnode dissection in men with prostate cancer treated with radical prostatectomy

Prospective randomized trial to evaluate the prognostic role of lymphnode dissection in men with prostate cancer treated with radical prostatectomy - PREDICT-Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00019941

Enrollment

3650

Registered

2020-01-10

Start date

2019-10-15

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

C61

Interventions

Group 1: Patients randomized to arm A undergo bilateral lymph node dissection in the pelvic area as part of prostatectomy. At least 10 lymph nodes must be removed. Group 2: Application of standardized

Eligibility

Sex/Gender

Male

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - localized intermediate risk prostate cancer (intermediate risk (PSA> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b) - scheduled for RRP or DVRP

Exclusion criteria

Exclusion criteria: - ASA (American Society of Anesthesiology) Classification> 3 - Existing contraindications for performing a lymph node dissection - Neoadjuvant hormone therapy

Design outcomes

Primary

Measure	Time frame
The PSA recurrence rate in patients with intermediate risk prostate cancer treated with radical prostatectomy with or without additional lymph node dissection at three years of follow up (PSA recurrence: PSA value = 0.2 ng / ml). After amendment, the follow-up is extended to 10 years.	—

Secondary

Measure	Time frame
- metastasis-free survival (radiological) - Incidence of lymphoceles and complications 6 months after surgery (Clavien classification) - incidence of adjuvant therapies (salvage LAD, hormone therapy, radiation) functional outcome (quality of life, continence, potency) After amendment, the follow-up is extended to 10 years.	—

Countries

Belgium, Germany

Contacts

Public ContactAnke Renter

Martini-Klinik am UKE GmbH

a.renter@uke.de040 741053115

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026