BridgeMD
A research study to compare the standard treatment and the study drug (degarelix) in combination with radiotherapy in patients with high-risk localized or locally-advanced cancer, who receive this treatment after initial radical prostatectomy or as primary therapy.
EU CTIS ID: 2024-513450-30-00
What this study is testing
To assess if GnRH antagonists improve PSA nadir within 6 months following completion of RT compared to GnRH agonists in combination with external beam radiation therapy in patients with high-risk localized or locally-advanced cancer, who receive this treatment as primary therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients may enter the trial in the clinical setting where a combination therapy involving irradiation combined with androgen deprivation therapy is envisaged.
- For all patients: Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1.5 109/L; hemoglobin ≥ 10.0 g/dl; platelets ≥ 100 109/L)
- For all patients: Adequate hepatic function: (1) Bilirubin: total bilirubin ≤ 1.5 x upper limit of normal (ULN). (2) AST and/or ALT ≤ 2.5 x ULN.
- For all patients: Adequate renal function: calculated creatinine clearance ≥ 50 mL/min
- For all patients: Magnesium and potassium within normal limits at the institution
- For all patients: WHO Performance status 0-1
You likely can't join if
- M1c, confirmed by any imaging method or biopsy
- Any contraindication to external beam radiotherapy
- Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial.
- Previous use of androgen deprivation therapy, antiandrogens if not interrupted for more than 6 months prior to entering the study
- History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angiodema.
- Hypersensitivity towards any of the active substances, the excipients used and synthetic GnRH or GnRH derivatives
See the full eligibility criteria
Who can join
- Patients may enter the trial in the clinical setting where a combination therapy involving irradiation combined with androgen deprivation therapy is envisaged.
- For all patients: Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1.5 109/L; hemoglobin ≥ 10.0 g/dl; platelets ≥ 100 109/L)
- For all patients: Adequate hepatic function: (1) Bilirubin: total bilirubin ≤ 1.5 x upper limit of normal (ULN). (2) AST and/or ALT ≤ 2.5 x ULN.
- For all patients: Adequate renal function: calculated creatinine clearance ≥ 50 mL/min
- For all patients: Magnesium and potassium within normal limits at the institution
- For all patients: WHO Performance status 0-1
- For all patients: Age ≥ 18 and ≤ 80 years
- For all patients: Participants who have partners of childbearing potential must use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after last dose of study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
- For all patients: Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- For patients planned for primary radiotherapy: Histologically confirmed diagnosis of prostate adenocarcinoma diagnosed on a systematic ultrasound guided biopsy of the prostate containing at least 8 cores. An MRI-fusion biopsy is allowed if taken because a previous biopsy was negative. A TURP specimen pathology is allowed. Two of the following 4 risk factors for relapse: PSA ≥20 ng/ml; Gleason sum ≥8; cN1 (regional LN with a short axis length >10mm by CT scan or MRI) or pathologically confirmed lymph nodes (pN1); cT3-T4 (by MRI or core biopsy).
- For all patients: Either of (1) M0 according to standard imaging methods (i.e. bone scan and conventional CT/MR image) or M0 according to modern imaging methods (i.e. whole-body MRI, PET/CT); (2) M0 according to bone scan and conventional CT/MR image and M1a and M1b only with ≤ 3 lesions detected by modern imaging methods are also allowed, called "Oligometastatic disease". Patients with oligometastatic disease will undergo metastasis targeted therapy.
- For all patients: Testosterone ≥ 200 ng/dL
What rules you out
- M1c, confirmed by any imaging method or biopsy
- Any contraindication to external beam radiotherapy
- Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial.
- Previous use of androgen deprivation therapy, antiandrogens if not interrupted for more than 6 months prior to entering the study
- History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angiodema.
- Hypersensitivity towards any of the active substances, the excipients used and synthetic GnRH or GnRH derivatives
- No severe hepatic impairment (Child Pugh C)
- Uncontrolled diabetes mellitus
- Coronary revascularization (PCI or multivessel CABG), carotid artery or iliofemoral artery revascularizaton (percutaneous or surgical procedure) within the last 30 days prior to entering the trial
- Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (eg, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >450 ms
- Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin), or the patient has been free of malignancy for a period of 3 years prior to first dose of study drug(s). Prior history of bladder cancer (except appropriately treated Tis or T1a) excludes the patient
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. 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 EU CTIS; the study team decides eligibility.