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 Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer
Brief Summary: The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.

Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.


Options:
A: 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.
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:

* 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.
D: Inclusion Criteria:

* Male patient with histologically confirmed prostate cancer (adenocarcinoma).
* Patient in whom endocrine treatment is indicated. Patient having undergoing prostatectomy or radiotherapy with curative intention and has a rising serum PSA (PSA ≥ 2 ng/mL at screening) may be included.
* Has a serum testosterone level above 2.2 ng/mL at screening.
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at screening.
* Has a serum PSA ≥ 2 ng/mL at screening.
* Has a life expectancy of at least 12 months.

Exclusion Criteria:

* Previous or present endocrine treatment for prostate cancer. Example: surgical castration, GnRH agonists, GnRH antagonists, antiandrogens or oestrogens, and 5α-reductase inhibitors.
* Received a 5α-reductase inhibitor within 25 weeks preceding screening.
* Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months.
* Has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema.
* Has hypersensitivity towards mannitol.
* Has a marked prolongation of QT/QTc interval (two consecutive increases to \>450 ms in QTc interval at retest) at screening.
* Has concurrent or a history of a disease (heart failure, hypokalemia, a family history of QT prolongation syndrome, etc.) that may induce Torsade de Pointes.

Answer: B