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.
- Conditions
- very high risk localized or locally advanced prostate cancerMedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-005098-19-BE
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 885
Patients may enter the trial once in either of two clinical settings where a combination therapy involving irradiation combined with androgen deprivation therapy is envisaged: a) patients who are scheduled for primary treatment by irradiation combined with minimum 18 months of androgen deprivation therapy or b) patients who were operated within the EORTC SPECTA 1553 study and who are scheduled to receive adjuvant or early salvage irradiation.
Entry criteria 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)
(ie. If PSA=20 ng/ml then only one of the other 3 risk factors is needed)
Entry criteria for patients previously enrolled in EORTC SPECTA 1553, treated by radical prostatectomy:
? Radical prostatectomy in EORTC SPECTA 1553performed within 1 year
? Scheduled to receive irradiation combined with 6 months of androgen deprivation therapy in the following cases:
? In the adjuvant setting with PSA = 0.1 ng/mL at 12 weeks post-surgery and/or = 2 pathologically confirmed positive nodes after radical prostatectomy
? For a biochemical recurrence (BCR) = 1 year after radical prostatectomy (defined as per guidelines as two consecutive rising serum PSA values greater than or equal to 0.2 ng/mL)
Entry criteria for all patients
Either of
?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)
? 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
Testosterone = 200 ng/dL
? Adequate bone marrow function (absolute neutrophil count (ANC) ? 1.5 109/L; hemoglobin = 10.0 g/dl; platelets ? 100 109/L)
? Adequate hepatic function:
? Bilirubin: total bilirubin ? 1.5 ? upper limit of normal (ULN).
? AST and/or ALT = 2.5 ? ULN.
? Adequate renal function: calculated creatinine clearance = 50 mL/min
? Magnesium and potassium within normal limits of at the institution
? WHO Performance status 0-1
? Age = 18 and = 80 years
? 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
? Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 295
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 590
? M1c, confirmed by any imaging method or biopsy
? 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
? 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method