Advanced Prostate Cancer, Lower Urinary Tract Symptoms
Conditions
Keywords
Prostate cancer, Lower urinary tract symptoms, Hormonotherapy, LHRH analogue, Androgen deprivation therapy (ADT)
Brief summary
The purpose of the study is to determine the influence of GnRH (gonadotropin releasing hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally advanced and/or metastatic prostate cancer and LUTS.
Detailed description
The remaining target is: \- to assess the intensity of LUTS in Polish and Ukrainian patients with locally advanced and metastatic prostate cancer, previously untreated with hormonal therapy
Interventions
DRUGLeuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
Leuprolide acetate 11.25 mg every 3 months sc or im, number of injections during the trial - 5 in Poland, Leuprolide acetate 3.75 mg every 1 month sc or im, number of injections during the trial - 12 in Ukraine.
Sponsors
Fraktal.com.pl
Med-net.pl
Abbott
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 50 years * Locally advanced (T3-T4) and/or metastatic (N+/M+) hormone-sensitive prostate cancer, confirmed by histological examination * Presence of lower urinary tract symptoms (LUTS)-IPSS \>0 * Treatment with Lucrin® Depot is the routine therapy in the patient. The decision as to Lucrin® Depot choice will not be associated with patient's participation in the study, but will result from the best medical knowledge and practice. * Until inclusion into PMOS the patient has not been treated with GnRH analogue. * The patient, before inclusion into the study, has not been treated by surgery (radical prostatectomy).
Exclusion criteria
* Patients will not be included into the study if any contraindications to treatment with Lucrin® Depot exist, or if there are other treatment options which, according to the present medical knowledge, are potentially more beneficial for the patient. * Physician or patient can stop treatment at any moment, if any indications or reasons exist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. | Baseline to 12 months | The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining \[rated as 0 (not at all) to 5 (almost always)\], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | Baseline to 3, 6, 9, and 12 months. | The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining \[rated as 0 (not at all) to 5 (almost always)\], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. |
| Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Baseline | Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present. |
| Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Baseline to 3, 6, 9, and 12 months. | Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present. |
| Reported Adverse Events/Serious Adverse Events | Baseline to 12 months | Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details. |
Countries
Poland, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Advanced PCa Patients With LUTS Treated With GnRH Analogue Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) | 729 |
| Total | 729 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Participant moved to another physician | 1 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Advanced PCa Patients With LUTS Treated With GnRH Analogue |
|---|---|
| Age at diagnosis of prostate cancer | 70.7 years STANDARD_DEVIATION 7.1 |
| Age Continuous | 71.2 years STANDARD_DEVIATION 7.2 |
| Gleason score 10 | 13 participants |
| Gleason score 2 | 1 participants |
| Gleason score 3 | 3 participants |
| Gleason score 4 | 35 participants |
| Gleason score 5 | 53 participants |
| Gleason score 6 | 151 participants |
| Gleason score 7 | 262 participants |
| Gleason score 8 | 167 participants |
| Gleason score 9 | 41 participants |
| Gleason score Lack of data | 3 participants |
| Prostate cancer type Advanced with metastases | 127 Participants |
| Prostate cancer type Lack of data | 1 Participants |
| Prostate cancer type Localized | 39 Participants |
| Prostate cancer type Locally advanced | 562 Participants |
| Prostate-Specific Antigen (PSA) concentration | 55.8 ng/mL STANDARD_DEVIATION 291.5 |
| Region of Enrollment Poland | 659 participants |
| Region of Enrollment Ukraine | 70 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 729 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 729 |
| serious Total, serious adverse events | 6 / 729 |
Outcome results
Primary
The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.
The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining \[rated as 0 (not at all) to 5 (almost always)\], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Time frame: Baseline to 12 months
Population: Analysis conducted in the intent-to-treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. | IPSS at Baseline (n=727) | 17.8 units on a scale | Standard Deviation 6.9 |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35. | IPSS at 12 months (n=699) | 10.0 units on a scale | Standard Deviation 5 |
Secondary
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.
Time frame: Baseline to 3, 6, 9, and 12 months.
Population: Analysis conducted in the intent-to-treat population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Hematospermia (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Lower abdominal pain (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Urinary incontinence (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Erectile dysfunction (Baseline; n=729) | 4 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 5 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 5 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 6 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 6 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Crotch pain (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Anal pain or bleeding (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Lumbar/back pain (Baseline n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Bone pain (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Spinal compression symptoms (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Periph. lymph node enlargement (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 12 (n=703) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | Lymphatic oedema, lower extrem. (Baseline; n=729) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 3 (n=726) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 6 (n=719) | 0 Units on a scale |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12. | >Month 9 (n=704) | 0 Units on a scale |
Secondary
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.
Time frame: Baseline
Population: Analysis conducted in the intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Hematospermia | 3 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Lower abdominal pain | 31 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Urine incontinence | 13 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Erectile dysfunction | 62 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Crotch pain | 24 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Anal pain or bleeding | 2 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Lumbar/back pain | 15 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Bone pain | 17 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Spinal compression symptoms | 1 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Peripheral lymph node enlargement | 2 Percentage of participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer. | Lymphatic oedema of the lower extremities | 6 Percentage of participants |
Secondary
Reported Adverse Events/Serious Adverse Events
Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details.
Time frame: Baseline to 12 months
Population: Analysis conducted in the intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Reported Adverse Events/Serious Adverse Events | Experienced a serious AE | 5 Participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Reported Adverse Events/Serious Adverse Events | Experienced a non-serious AE | 3 Participants |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | Reported Adverse Events/Serious Adverse Events | Experienced both a serious AE and non-serious AE | 1 Participants |
Secondary
The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining \[rated as 0 (not at all) to 5 (almost always)\], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Time frame: Baseline to 3, 6, 9, and 12 months.
Population: Analysis conducted in the intent-to-treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | IPSS at Baseline (n=727) | 17.8 units on a scale | Standard Deviation 6.9 |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | IPSS at month 3 (n=724) | 14.0 units on a scale | Standard Deviation 5.6 |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | IPSS at month 6 (n=717) | 12.3 units on a scale | Standard Deviation 5.1 |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | IPSS at month 9 (n=702) | 10.9 units on a scale | Standard Deviation 4.9 |
| Advanced PCa Patients With LUTS Treated With GnRH Analogue | The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months. | IPSS at month 12 (n=699) | 10.0 units on a scale | Standard Deviation 5 |