Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer

Prostatic Neoplasm Clinical Trial

Official title:

A Post-Marketing Observational Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatment of Advanced Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081873
• Other study ID #: PMOS-BELG-04-001
• Status: Completed
• Phase: N/A
• First received: February 27, 2010
• Last updated: October 26, 2012
• Start date: June 2004
• Est. completion date: December 2010

Study information

• Verified date: October 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and alternative therapeutic approaches to the treatment of advanced prostate cancer during normal clinical practice and in accordance with the terms of the Belgian marketing authorization and reimbursement conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2717
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with advanced prostate cancer who have been prescribed Lucrin/ Lucrin-Tri-depot or any other treatment with local reimbursement guidelines; Patients willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

• Contraindications according to the Summary of Product Characteristics (SPC).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• leuprolide (Lucrin/Lucrin-Tri-depot)
Subcutaneous or intramuscular administration for all participants

Locations

Country	Name	City	State
Belgium	Site Reference ID/Investigator# 31196	Aartselaar
Belgium	Site Reference ID/Investigator# 31237	Afsnee
Belgium	Site Reference ID/Investigator# 31121	Alken
Belgium	Site Reference ID/Investigator# 31186	Antwerp
Belgium	Site Reference ID/Investigator# 4872	Antwerp
Belgium	Site Reference ID/Investigator# 31170	Antwerpen
Belgium	Site Reference ID/Investigator# 31194	Antwerpen
Belgium	Site Reference ID/Investigator# 31141	Arlon
Belgium	Site Reference ID/Investigator# 31199	Arlon
Belgium	Site Reference ID/Investigator# 31247	Ath
Belgium	Site Reference ID/Investigator# 31190	Baulers
Belgium	Site Reference ID/Investigator# 31210	Beerse
Belgium	Site Reference ID/Investigator# 31171	Berchem
Belgium	Site Reference ID/Investigator# 31137	Berlaar
Belgium	Site Reference ID/Investigator# 31204	Beveren
Belgium	Site Reference ID/Investigator# 31184	Boutersem
Belgium	Site Reference ID/Investigator# 31205	Braine-Le-Chateau
Belgium	Site Reference ID/Investigator# 31217	Brasschaat
Belgium	Site Reference ID/Investigator# 31133	Bruges
Belgium	Site Reference ID/Investigator# 31135	Bruges
Belgium	Site Reference ID/Investigator# 31134	Brugge
Belgium	Site Reference ID/Investigator# 31232	Brussels
Belgium	Site Reference ID/Investigator# 31233	Brussels
Belgium	Site Reference ID/Investigator# 31252	Brussels
Belgium	Site Reference ID/Investigator# 31117	Bruxelles
Belgium	Site Reference ID/Investigator# 31152	Bruxelles
Belgium	Site Reference ID/Investigator# 31161	Bruxelles
Belgium	Site Reference ID/Investigator# 31178	Bruxelles
Belgium	Site Reference ID/Investigator# 31200	Bruxelles
Belgium	Site Reference ID/Investigator# 31203	Bruxelles
Belgium	Site Reference ID/Investigator# 31223	Bruxelles
Belgium	Site Reference ID/Investigator# 31236	Bruxelles
Belgium	Site Reference ID/Investigator# 31251	Bruxelles
Belgium	Site Reference ID/Investigator# 31129	Court St. Etienne
Belgium	Site Reference ID/Investigator# 31244	Cuesmes
Belgium	Site Reference ID/Investigator# 31208	Damme
Belgium	Site Reference ID/Investigator# 31155	Dendermonde
Belgium	Site Reference ID/Investigator# 31197	Dendermonde
Belgium	Site Reference ID/Investigator# 31189	Diest
Belgium	Site Reference ID/Investigator# 31126	Dilbeek
Belgium	Site Reference ID/Investigator# 31116	Dworp
Belgium	Site Reference ID/Investigator# 31160	Dworp
Belgium	Site Reference ID/Investigator# 31179	Elingen
Belgium	Site Reference ID/Investigator# 31249	Embourg
Belgium	Site Reference ID/Investigator# 31166	Erpent
Belgium	Site Reference ID/Investigator# 31192	Esneux
Belgium	Site Reference ID/Investigator# 31188	Falmagne
Belgium	Site Reference ID/Investigator# 31195	Feluy
Belgium	Site Reference ID/Investigator# 31250	Floreffe
Belgium	Site Reference ID/Investigator# 31183	Genk
Belgium	Site Reference ID/Investigator# 31173	Genk-Waterschei
Belgium	Site Reference ID/Investigator# 31228	Gent
Belgium	Site Reference ID/Investigator# 46502	Gent
Belgium	Site Reference ID/Investigator# 31132	Gouy-Les-Pietons
Belgium	Site Reference ID/Investigator# 31124	Halle
Belgium	Site Reference ID/Investigator# 31191	Hamme
Belgium	Site Reference ID/Investigator# 31234	Hasselt
Belgium	Site Reference ID/Investigator# 31227	Heusy
Belgium	Site Reference ID/Investigator# 31212	Hofstade
Belgium	Site Reference ID/Investigator# 31143	Hove
Belgium	Site Reference ID/Investigator# 31226	Huy
Belgium	Site Reference ID/Investigator# 31119	Izegem
Belgium	Site Reference ID/Investigator# 31181	Izegem
Belgium	Site Reference ID/Investigator# 31149	Knokke
Belgium	Site Reference ID/Investigator# 31177	Koksijde
Belgium	Site Reference ID/Investigator# 31253	Kortrijk
Belgium	Site Reference ID/Investigator# 31130	Lasne
Belgium	Site Reference ID/Investigator# 31159	Lennik
Belgium	Site Reference ID/Investigator# 31123	Leper
Belgium	Site Reference ID/Investigator# 31241	Leper
Belgium	Site Reference ID/Investigator# 31255	Lesves
Belgium	Site Reference ID/Investigator# 31259	Leuven
Belgium	Site Reference ID/Investigator# 31219	Libramont
Belgium	Site Reference ID/Investigator# 31128	Liege
Belgium	Site Reference ID/Investigator# 31144	Liege
Belgium	Site Reference ID/Investigator# 31185	Liege
Belgium	Site Reference ID/Investigator# 31207	Liege
Belgium	Site Reference ID/Investigator# 31245	Liege
Belgium	Site Reference ID/Investigator# 31224	Lier
Belgium	Site Reference ID/Investigator# 31243	Lommel
Belgium	Site Reference ID/Investigator# 31225	Marcinelle
Belgium	Site Reference ID/Investigator# 31139	Marcq
Belgium	Site Reference ID/Investigator# 31206	Mol
Belgium	Site Reference ID/Investigator# 31153	Mons
Belgium	Site Reference ID/Investigator# 31257	Mons
Belgium	Site Reference ID/Investigator# 31140	Mont-sur-Marchienne
Belgium	Site Reference ID/Investigator# 31222	Mortsel
Belgium	Site Reference ID/Investigator# 31164	Namur
Belgium	Site Reference ID/Investigator# 31258	Nivelles
Belgium	Site Reference ID/Investigator# 31218	Oordegem
Belgium	Site Reference ID/Investigator# 31214	Oostende
Belgium	Site Reference ID/Investigator# 31242	Oostende
Belgium	Site Reference ID/Investigator# 31156	Oosterzele
Belgium	Site Reference ID/Investigator# 31131	Ottignies
Belgium	Site Reference ID/Investigator# 31163	Oudenaarde
Belgium	Site Reference ID/Investigator# 31125	Overijse
Belgium	Site Reference ID/Investigator# 31198	Pollinkhove
Belgium	Site Reference ID/Investigator# 31229	Ragnies
Belgium	Site Reference ID/Investigator# 31138	Rijmenam
Belgium	Site Reference ID/Investigator# 31122	Roeselare
Belgium	Site Reference ID/Investigator# 31174	Roeslare
Belgium	Site Reference ID/Investigator# 31136	Rotselaar
Belgium	Site Reference ID/Investigator# 31180	Rumbeke
Belgium	Site Reference ID/Investigator# 31147	S. Gravenwezel
Belgium	Site Reference ID/Investigator# 31215	Saint Ghislain
Belgium	Site Reference ID/Investigator# 31176	Saintes
Belgium	Site Reference ID/Investigator# 31168	Schilde
Belgium	Site Reference ID/Investigator# 31220	Schoten
Belgium	Site Reference ID/Investigator# 31238	Schoten
Belgium	Site Reference ID/Investigator# 31142	Seneffe
Belgium	Site Reference ID/Investigator# 31158	Seraing
Belgium	Site Reference ID/Investigator# 31246	Silly
Belgium	Site Reference ID/Investigator# 31240	Sint Niklaas
Belgium	Site Reference ID/Investigator# 31120	Sint Truiden
Belgium	Site Reference ID/Investigator# 31230	Sint-Genesius-Rode
Belgium	Site Reference ID/Investigator# 31213	Sirault
Belgium	Site Reference ID/Investigator# 31150	St Denis
Belgium	Site Reference ID/Investigator# 31157	St. Truiden
Belgium	Site Reference ID/Investigator# 31182	Tielt
Belgium	Site Reference ID/Investigator# 31248	Tilff
Belgium	Site Reference ID/Investigator# 31151	Tournai
Belgium	Site Reference ID/Investigator# 31146	Tremelo
Belgium	Site Reference ID/Investigator# 31254	Uccle
Belgium	Site Reference ID/Investigator# 31256	Uccle
Belgium	Site Reference ID/Investigator# 31165	Veerle
Belgium	Site Reference ID/Investigator# 31193	Villers-Saint-Simeon
Belgium	Site Reference ID/Investigator# 31175	Wanze
Belgium	Site Reference ID/Investigator# 31145	Waregem
Belgium	Site Reference ID/Investigator# 31202	Wilrijk
Belgium	Site Reference ID/Investigator# 31201	Woluwe St Pierre
Belgium	Site Reference ID/Investigator# 31216	Xhendelesse
Luxembourg	Site Reference ID/Investigator# 31221	Bascharage
Luxembourg	Site Reference ID/Investigator# 31172	Esch-sur-Alzette
Luxembourg	Site Reference ID/Investigator# 31162	Ettelbruck
Luxembourg	Site Reference ID/Investigator# 31231	Luxembourg

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

Belgium,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit	The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.	time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first	No
Primary	Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit	The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.	time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first	No
Primary	Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit	Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator.	month 3, and every 3 months until disease progression or up to 24 months, whichever came first	No
Primary	Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months	The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and < 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator.	time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first	No
Primary	Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.	Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy).	time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first	No
Secondary	Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)	The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details.	Baseline to disease progression or 24 months, whichever came first	Yes
Secondary	Epidemiological Data: Mean Weight	The mean weight of all participants at baseline is provided.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: Mean Age	The mean age of all participants at baseline is provided.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: Race	The number of participants by race at baseline is presented.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.	Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: PSA at Baseline	The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.	The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.	The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test	In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.	N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: Bone Scan at Baseline	The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist.	at time 0 (Baseline)	No
Secondary	Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline	The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes.	at time 0 (Baseline)	No