Testing Length of Hormone Therapy With Radiation After Prostate Cancer Returns
Compares short and long hormone therapy with high-dose radiation in men whose prostate cancer returned.
Plain-language title generated from the registry record
Registry title: Long-term Better Than Short-term ADT With Salvage RT
Key facts
- Where
- Ghent and Leuven, BelgiumSee the 3 sites
- Phase
- Phase 2/3
Where in Belgium
- AZ Maria MiddelaresGhent, BelgiumTaking people
- UZ GentGhent, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT04242017
- Record updated
- 13 December 2023
- Original description
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.Read full original descriptionShow less
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 Patients With Biochemical Relapse After Radical Prostatectomy
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.
Inclusion: 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; 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; Testosterone levels within above 150 ng/dl; ECOG 0-1; Life expectancy more than 5 years; Signed informed consent.
Exclusion: Previous RT making new RT impossible (overlapping treatment fields); Active treatment with ADT or PSA modulating drugs (finasteride, dutasteride, high-dose corticoids…); Presence of pN1 disease at original surgical specimen; Known contraindications to irradiation (Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia…); 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; Undetectable PSA (less than 0.2 ng/ml) at time of referral; Not able understanding treatment protocol or signing informed consent.