Actively Recruiting
Long-term Better Than Short-term ADT With Salvage RT
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2023-12-13
394
Participants Needed
3
Research Sites
551 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-term Better Than Short-term ADT With Salvage RT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of confirmed prostate cancer treated with radical prostatectomy and extended pelvic lymph node dissection including removal of external iliac, internal iliac, and obturator nodes
- Node-negative status (pN0) confirmed after surgery
- Asymptomatic PSA rise post-prostatectomy of at least 0.2 µg/l confirmed twice, or from 0.15 µg/l for high-risk cases (Gleason 8-10, pT3b, or positive margins)
- No additional staging required if PSA less than 0.4 ng/ml; mandatory PSMA PET-CT imaging if PSA above 0.4 ng/ml
- Testosterone level above 150 ng/dl
- ECOG performance status 0 or 1
- Life expectancy longer than 5 years
- Signed informed consent
You will not qualify if you...
- Presence of lymph node-positive disease (pN1) at surgery
- Evidence of distant metastasis at referral (M1a-c), confirmed by PET-CT if PSA above 0.4 ng/ml
- PSA below 0.2 ng/ml at referral
- Prior radiotherapy preventing new radiotherapy due to overlapping fields
- Known contraindications to radiation therapy (e.g., Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia)
- Current treatment with ADT or PSA-affecting drugs (e.g., finasteride, dutasteride, high-dose corticosteroids)
- Inability to understand the treatment protocol or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
AZ Maria Middelares
Ghent, Belgium
Actively Recruiting
2
UZ Gent
Ghent, Belgium
Actively Recruiting
3
UZ Leuven
Leuven, Belgium
Actively Recruiting
Research Team
C
Charlien Berghen, MD
CONTACT
G
Gert De Meerleer, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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