Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
Brief Summary: The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.


Options:
A: Inclusion Criteria:

* Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
* Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment.
* Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level (measured at a central laboratory) must be \>4 ng/mL and ≤50 ng/mL.
* Patients with Localised Prostate Cancer or Patients with Previous Therapy with Curative Intention and a Rising PSA - PSA doubling time (based on patient records at the trial site) must be \<24 months. There is no minimum PSA level required and the maximum PSA must be ≤50 ng/mL.
* Is a male patient aged 18 years or older.
* Has an Eastern Cooperative Oncology Group score of ≤2.
* Has a life expectancy of at least 24 months.

Exclusion Criteria:

* Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including gonadotropin releasing hormone (GnRH) receptor agonists, GnRH antagonists, anti-androgens, 5-alpha reductase inhibitors and estrogens). However, for patients having undergone prostatectomy or radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to Screening Visit.
* Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
* Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Has hypersensitivity towards any component of the investigational medicinal product.
* Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
* Has a known or suspected clinically significant liver and/or biliary disease.
* Has a history of or risk factors for Torsades de Pointes
* At time of inclusion receives concomitant medications that might prolong the QT interval.
* Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient's health or the outcome of the trial.
* Has a clinically significant disorder (other than prostate cancer) including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the investigator.
* Has severe kidney failure (creatinine clearance \<30 mL/min), based on the serum creatinine value at Screening Visit and calculated by Cockcroft-Gault algorithm (only valid in France).
* Has a mental incapacity or language barriers precluding adequate understanding or co operation.
* Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial.
* Has previously participated in any degarelix trial
B: Inclusion Criteria:

* Patient has given written informed consent before any trial-related activity is performed
* Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion Criteria:

* Previous treatment for prostate cancer
* Previous trans-urethral resection of the prostate
* Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
* Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
* Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Hypersensitivity towards any component of the investigational product
* Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
* Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
C: Inclusion Criteria:

* Men \>18 and =\< 75 years of age
* Willing and able to provide informed consent, either alone or with the aid of a translator
* Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
* Gleason Score \>= 7and/or prostate cancer that is clinical stage T2 disease.
* Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation
* Normal organ and marrow function as defined by the following criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole)
* History of receiving radiation to the pelvic area.
* Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization.
* History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Known hypersensitivity towards any component of the investigational medicinal product or Casodex (bicalutamide) or their excipients.
* Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval \>450 ms).
* History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome).
* Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
* Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial.
* Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to randomization.
* Mental incapacity or language barrier precluding adequate understanding or co operation.
* Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial.
* Previously participated in any degarelix trial.
D: Inclusion Criteria:

* Patient has given written informed consent before any trial-related activity is performed.
* Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion Criteria:

* Previous treatment for prostate cancer
* Previous trans-urethral resection of the prostate
* Patients who are lymph node positive or have other metastatic disease
* Use of urethral catheter
* Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
* History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
* Hypersensitivity towards any component of the investigational product
* Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
* Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
* Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

Answer: D