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Antineoplastic Agents, Hormonal

Patients with advanced prostate cancer and lower urinary tract symptoms treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in 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.

Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)

Jozef Haczynski, MD, PhD

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.

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

Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)

Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.

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 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 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.

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.

Fraktal.com.pl

Med-net.pl

Abbott

The adverse event population includes all enrolled participants.

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)

Advanced PCa Patients With LUTS Treated With GnRH Analogue

Age Continuous

Sex: Female, Male

Poland

Ukraine

Region of Enrollment

Age of participant when diagnosed with prostate cancer. Results based on 724 participants.

Age at diagnosis of prostate cancer

The mean prostate-specific antigen (PSA) concentration at Baseline. Results based on 718 participants.

Prostate-Specific Antigen (PSA) concentration

Locally advanced

Advanced with metastases

Localized

Lack of data

Prostate cancer type

The Gleason score classifies each participant's prostate cancer based on how the cells look under the microscope. Prostate cancers often have areas with different grades, so a grade is assigned to the 2 areas that make up most of the cancer. The Gleason score is the sum of these 2 grades, resulting in a number from 2 to 10. The higher the Gleason score the more likely it is that the cancer will grow faster and spread beyond the prostate.

Gleason score

Global Medical Services

IPSS at Baseline (n=727)

IPSS at 12 months (n=699)

Analysis conducted in the intent-to-treat population.

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 month 3 (n=724)

IPSS at month 6 (n=717)

IPSS at month 9 (n=702)

IPSS at month 12 (n=699)

The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.

Hematospermia

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

Lymphatic oedema of the lower extremities

Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.

Hematospermia (Baseline; n=729)

>Month 3 (n=726)

>Month 6 (n=719)

>Month 9 (n=704)

>Month 12 (n=703)

Lower abdominal pain (Baseline; n=729)

Urinary incontinence (Baseline; n=729)

Erectile dysfunction (Baseline; n=729)

Crotch pain (Baseline; n=729)

Anal pain or bleeding (Baseline; n=729)

Lumbar/back pain (Baseline n=729)

Bone pain (Baseline; n=729)

Spinal compression symptoms (Baseline; n=729)

Periph. lymph node enlargement (Baseline; n=729)

Lymphatic oedema, lower extrem. (Baseline; n=729)

Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.

Experienced a serious AE

Experienced a non-serious AE

Experienced both a serious AE and non-serious AE

Reported Adverse Events/Serious Adverse Events

Overall Study

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Bicalutamide

Glucocorticoids

Hormones

Hormone Antagonists

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Androgen Antagonists

Patients will receive degarelix OR leuprolide with bicalutamide.

Patients will receive apalutamide and either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.

Patients will receive apalutamide and abiraterone acetate, in addition to either degarelix OR leuprolide. Patients on this arm will NOT take bicalutamide at any point in the treatment course.

Take apalutamide 240 mg (four 60 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.

Apalutamide

Patients will receive a LHRH analogue therapy of either Degarelix OR Leuprolide with bicalutamide.

Degarelix:

Patients will receive subcutaneous injections every 28 days (+/- 3 days). Patients will receive a loading dose of 240 mg (two 120 mg injections) on C1D1, followed by maintenance dose of 80 mg on Day 1 of subsequent cycles.

Leuprolide:

Patients treated with leuprolide will receive a 7.5 mg IM injection on C1D1. Patients in arm A ONLY will take this in combination with bicalutamide 50 mg orally once daily starting on C1D1 and continuing for 28 days through completion of cycle 1. Starting on C2D1, patients will continue on one of the following two treatments at investigator discretion:

1. Leuprolide 7.5 mg IM injection on Day 1 of subsequent cycles without concurrent bicalutamide.

   OR:
2. Leuprolide 22.5 mg IM injection at the following visits without concurrent bicalutamide: C2D1, C5D1, C8D1, and C11D1.

LHRH Analogue

Take abiraterone acetate 1000 mg (four 250 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.

Take two prednisone 5 mg tablets daily, starting on C1D1 and continuing throughout the 52-week treatment period. Following completion of treatment period, patients will taper off prednisone per institutional guidelines. Suggested tapering plan: prednisone 5 mg daily for 7 days, then 2.5 mg daily for 7 days before discontinuing.

Suzanne George, MD

Rahul Aggarwal, MD

This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.

Patients will be stratified by PSA doubling time (\< 3 months vs. 3-9 months) and randomized in 1:1:1 fashion to one of three treatment arms: (1) Control arm consisting of LHRH analogue monotherapy (degarelix or leuprolide), (2) Experimental arm consisting of apalutamide in combination with LHRH analogue, and (3) Experimental arm consisting of apalutamide, abiraterone acetate + prednisone, and LHRH analogue. Patients will be treated for a maximum duration of 52 weeks and then enter follow up phase until the time of PSA progression, development of metastasis, or patient withdrawal from study, whichever occurs first. Patients with PSA progression will be followed long term until the development of castration resistance, first metastasis, and death.

The primary endpoint of the study is PSA progression-free survival in the intent-to-treat patient population. PSA progression during the 52-week treatment period is defined as a rising PSA confirmed on repeat measurement, and at least 25% and 2 ng/mL above nadir or baseline, whichever is lower. PSA progression during follow up defined as PSA \> 0.2 ng/mL confirmed by repeat measurement at least 2 weeks later. Secondary study endpoints include PSA progression-free survival in testosterone-evaluable population, 36-month PSA progression-free survival rate in both intent-to-treat and testosterone-evaluable populations, time to testosterone recovery, time to castration resistance, metastasis-free survival, quality of life, and safety. Each experimental arm will be compared against the control arm in pair-wise fashion. The study is not powered to detect differences in primary or secondary endpoints between the two experimental arms.

A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

To compare PSA progression-free survival in each of the experimental arms (LHRH analogue + apalutamide; LHRH analogue + apalutamide +abiraterone acetate) versus the control arm (LHRH analogue) among all randomized patients (intent-to-treat population).

Compare PSA progression-free survival in testosterone-evaluable population in each experimental arm versus the control arm. Testosterone-evaluable population includes all patients who achieve serum testosterone recovery to \> 50 ng/dL with subsequent PSA measurements sufficient for evaluation

To compare the 36-month PSA progression-free survival rate in each experimental arm versus the control arm in both the intent-to-treat and testosterone-evaluable populations.

To compare the time to recovery of serum testosterone to greater than 50 ng/dL in each experimental arm versus the control arm.

To compare the time to castration resistance in each experimental arm versus the control arm.

To compare metastasis-free survival in each experimental arm versus the control arm.

To compare overall survival in each experimental arm versus the control arm.

To characterize the safety profile in each treatment arm

Expanded Prostate Cancer Index Composite (EPIC)

Hot Flash Daily Interference Scale (HFRDIS)

To compare the quality-adjusted survival (overall survival multiplied by utility score) of patients in each experimental arm versus the control arm.

Janssen Research & Development, LLC

Alliance Foundation Trials, LLC.

Goserelin

Prolactin Release-Inhibiting Factors

Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy.

Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.

1000 mg oral daily for 3 months followed by a prostatectomy.

LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.

LHRHa

Cougar Biotechnology, Inc. Clinical Trial

Christopher Logothetis, MD

The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone.

Objectives:

Primary Objective:

To assess the difference in pathologic stage \< pT2 between Group A and Group B.

Secondary Objective:

* To assess and compare the changes in levels of androgens (pre, during, and post treatment) in the serum, primary tumor microenvironment and bone marrow between Group A and Group B.
* To assess changes in biomarkers related to androgen signaling and other cancer-related pathways between Group A and Group B.
* To assess the difference in rate of positive surgical margins between Group A and Group B.
* To assess the safety profile of abiraterone acetate and low dose prednisone in a preoperative setting.

Study Groups:

Participants who are eligible to take part in this study will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:

* Those who are in Group A will take abiraterone acetate, a LHRH analogue, and prednisone.
* Those who are in Group B will receive a LHRH analogue alone. Participants will have 2 out of 3 chances of being placed in Group A or 1 out of 3 chances of being placed in Group B.

Participants in both groups will receive the study drug(s) for about 3 months followed by a prostatectomy (prostate surgery) between 2 and 4 weeks after they stop taking the study drug(s).

Length of Study:

Participants will receive study drugs on this study for about 3 months before having surgery to remove their prostate about 2-4 weeks later. Participants will be removed from this study if the disease gets worse, if they experience intolerable side effects, or their study doctors feel that it is in their best interest to stop the study.

Long-Term Follow-Up:

Participants will return to the clinic 1 month, 3 months, 6 months, and then every 6 months (for up to 8 years) after your surgery for follow-up visits. Up to 66 patients will be take part in this study. All will be enrolled at M. D. Anderson after their surgery.

Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer

A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone

The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.

The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate.

The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.

Cougar Biotechnology, Inc.

Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy

AA+LHRHa

Total

Age, Continuous

Senior Director

Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.

Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)

Number of Participants With a Positive Surgical Margin at Radical Prostatectomy

Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)	NCT01078545	Advanced Prosta... Lower Urinary T...	Leuprolide acet...	50 Years -	Abbott
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer	NCT03009981	Prostate Cancer	Apalutamide LHRH Analogue Abiraterone Ace... Prednisone	18 Years -	Alliance Foundation Trials, LLC.
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer	NCT01088529	Prostate Cancer	Abiraterone Ace... Prednisone LHRHa	18 Years -	Cougar Biotechnology, Inc.
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer	NCT01088529	Prostate Cancer	Abiraterone Ace... Prednisone LHRHa	18 Years -	Cougar Biotechnology, Inc.
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer	NCT03009981	Prostate Cancer	Apalutamide LHRH Analogue Abiraterone Ace... Prednisone	18 Years -	Alliance Foundation Trials, LLC.

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