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Compares treatment options for Prostate Cancer
Official title Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624
ClinicalTrials.gov ID: NCT05781217
What this study is testing
What is triptorelin, goserelin, leuprorelin?
triptorelin, goserelin, leuprorelin is an investigational medicine, given as an injectable 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
- The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published. NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation.
- 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
Ages 18 and older
You may be able to join if
- Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are...
- Biochemical recurrence after prostatectomy: BCR is defined as a PSA value ≥ 0.2 ng/mL, with at least one confirmatory PSA determination ≥ two weeks...
- Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18): CHARACTERISTICS...
- Testosterone level \> 150 ng/dL at inclusion
- ECOG 0-1
You likely can't join if
- Presence of pN1 disease in the original surgical specimen
- Presence of macroscopic disease on imaging tests. If the PSA at diagnosis is \> 0.4 ng/mL, then imaging tests (CT and bone scan and/or PET/CT or body...
- PSA \<0.2 or \<0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen).
- Previous pelvic radiotherapy
- Radiotherapy contraindicated
- Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)
See the full eligibility criteria
- Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion.
- Biochemical recurrence after prostatectomy: BCR is defined as a PSA value ≥ 0.2 ng/mL, with at least one confirmatory PSA determination ≥ two weeks after the first test (the confirmatory PSA level must be higher than...
- Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18): CHARACTERISTICS INTERMEDIATE RISK (≥ 2) HIGH RISK(≥ 1) PSA at diagnosis, ng/mL 0.6-1.0 ≥1.0 PSA...
- Testosterone level \> 150 ng/dL at inclusion
- ECOG 0-1
- Life expectancy \> 5 years
- Signed informed consent
- Presence of pN1 disease in the original surgical specimen
- Presence of macroscopic disease on imaging tests. If the PSA at diagnosis is \> 0.4 ng/mL, then imaging tests (CT and bone scan and/or PET/CT or body magnetic resonance imaging [MRI]) are required.
- PSA \<0.2 or \<0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen).
- Previous pelvic radiotherapy
- Radiotherapy contraindicated
- Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)
- Inability to understand the treatment protocol or sign informed consent
The study team makes the final eligibility decision.
Where it's taking place
- L'Hospitalet de Llobregat, Barcelona, Spain
- Fuenlabrada, Madrid, Spain
- Pozuelo de Alarcón, Madrid, Spain
- Barakaldo, Vizcaya, Spain
- Barcelona, Spain
- Madrid, Spain
- Tarragona, Spain
- Valencia, Spain
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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include L'Hospitalet de Llobregat, Barcelona, Spain; Fuenlabrada, Madrid, Spain; Pozuelo de Alarcón, Madrid, Spain; Barakaldo, Vizcaya, Spain; Barcelona, Spain; Madrid, Spain and 2 more location(s). 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.