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New treatment option for Prostate Cancer
Official title Long-term Better Than Short-term ADT With Salvage RT
ClinicalTrials.gov ID: NCT04242017
What this study is testing
What is Triptoreline?
Triptoreline is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, men only
You may be able to join if
- History of histologically proven prostate cancer, treated with RP and ePLND. All patients have to be pN0. The minimal template for ePLND is defined...
- 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...
- Testosterone levels within above 150 ng/dl.
- ECOG 0-1
- Life expectancy more than 5 years
You likely can't join if
- Presence of pN1 disease at original surgical specimen.
- 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...
- Undetectable PSA (less than 0.2 ng/ml) at time of referral.
- Previous RT making new RT impossible (overlapping treatment fields).
- Known contraindications to irradiation (Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia…)
- Active treatment with ADT or PSA modulating drugs (finasteride, dutasteride, high-dose corticoids…)
See the full eligibility criteria
- 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...
- 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...
- Testosterone levels within above 150 ng/dl.
- ECOG 0-1
- Life expectancy more than 5 years
- Signed informed consent
- Presence of pN1 disease at original surgical specimen.
- 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...
- Undetectable PSA (less than 0.2 ng/ml) at time of referral.
- Previous RT making new RT impossible (overlapping treatment fields).
- Known contraindications to irradiation (Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia…)
- Active treatment with ADT or PSA modulating drugs (finasteride, dutasteride, high-dose corticoids…)
- Not able understanding treatment protocol or signing informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.