Long-term Better Than Short-term ADT With Salvage RT

  • Recruiting
  • Treatment
  • Interventional
  • Randomized
  • Drug
  • PHASE2/PHASE3
  • Universitaire Ziekenhuizen KU Leuven
  • -


Study Purpose

A randomized, multicenter, prospective PHASE II trial to assess the effect of short- versus long-term adjuvant ADT with high dose salvage radiotherapy on distant metastasis free survival in case of biochemical relapse (BR) after radical prostatectomy.

Intervention

Drug : Triptoreline


Eligibility Requirements

info icon History of histologically proven prostate cancer, treated with RP and ePLND. All patients have to be pN0. The minimal template for ePLND is defined as the removal of the external iliac, internal iliac and obturator nodes (standard template). Removal of the presacral and common iliac nodes is left at the discretion of the treating urologist.

info icon Asymptomatic PSA-rise post-RP, defined as a value equal to or more than 0.2µg/l and at least confirmed once (interval ≥2 weeks, confirmation PSA level should be higher). In case of Gleason 8-10, pT3b or R1 resection, an asymptomatic PSA-rise post-RP starting from ≥0.15 µg/l is allowed for inclusion. If the PSA-level is less than 0.4 ng/ml, no additional staging for distant metastasis is required before inclusion in the trial. The patient will be offered the opportunity to participate in a diagnostic sub-study with investigational imaging with 18F PSMA PET CT. However in case of PSA-level \>0.4 ng/ml, biological imaging using 18F-PSMA or 68Ga-PSMA is mandatory as this is not considered investigational anymore. Therefore the patient cannot anymore take part in the diagnostic sub-study and (un-blinded) PET-CT is obligatory to rule out lymph node (N) and /or distant metastasis (M1a-c) before inclusion.

info icon Testosterone levels within above 150 ng/dl.

info icon ECOG 0-1

info icon Life expectancy more than 5 years

info icon Signed informed consent

info icon Minimum age: 18

info icon Presence of pN1 disease at original surgical specimen.

info icon Presence of distant metastasis at time of referral (M1a-c). If PSA more than 0.4 ng/ml, imaging with PET-CT is required to rule out distant metastasis (see above). Other additional imaging modalities (CT scan, bone scintigraphy...) are allowed but left at the discretion of the treating centre.

info icon Undetectable PSA (less than 0.2 ng/ml) at time of referral.

info icon Previous RT making new RT impossible (overlapping treatment fields).

info icon Known contraindications to irradiation (Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia...)

info icon Active treatment with ADT or PSA modulating drugs (finasteride, dutasteride, high-dose corticoids...)

info icon Not able understanding treatment protocol or signing informed consent.

Recruiting status

Recruiting

Estimated enrollment

394

 
Study start date

Jul 07, 2020

Study end date

Feb 01, 2031

Last updated

Mar 22, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE2/PHASE3

Allocation

Randomized

 

Sponsor:

Universitaire Ziekenhuizen KU Leuven

Collaborator:

Ipsen

Investigator:

Gert De Meerleer, MD, PhD

NCT04242017

Clinic Location Investigator Distance RECRUITING STATUS Contact