Prostatic NeoplasmNCT01081873

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

An observational study of Prostatic Neoplasm, run by Abbott at 135 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostatic Neoplasm
What is being tested?: leuprolide (Lucrin/Lucrin-Tri-depot)
Type of treatment: Injection or infusion
How many people: 2,717 participants
Where: 135 sitesin 2 countries
Study dates: Jun 2004to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: Urologists

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

135 sites in 2 countries.

Country

City, postcode or hospital

135 sites in 2 countries

Belgium131 sites

Site Reference ID/Investigator# 31147
's-Gravenwezel, B-2970
Site Reference ID/Investigator# 31196
Aartselaar, B-2630
Site Reference ID/Investigator# 31237
Afsnee, B-9051
Site Reference ID/Investigator# 31121
Alken, B-3570
Site Reference ID/Investigator# 31170
Antwerp, B-2018
Site Reference ID/Investigator# 31194
Antwerp, B-2018
Site Reference ID/Investigator# 4872
Antwerp, B-2020
Site Reference ID/Investigator# 31186
Antwerp, B-2050
Site Reference ID/Investigator# 31141
Arlon, B-6700
Site Reference ID/Investigator# 31199
Arlon, B-6700
Site Reference ID/Investigator# 31247
Ath, B-7804
Site Reference ID/Investigator# 31190
Baulers, B-1401
Site Reference ID/Investigator# 31210
Beerse, B-2340
Site Reference ID/Investigator# 31171
Berchem, B-2600
Site Reference ID/Investigator# 31137
Berlaar, B-2590
Site Reference ID/Investigator# 31204
Beveren, B-8800
Site Reference ID/Investigator# 31184
Boutersem, B-3370
Site Reference ID/Investigator# 31205
Braine-le-Château, B-1440
Site Reference ID/Investigator# 31217
Brasschaat, B-2930
Site Reference ID/Investigator# 31133
Bruges, B-8310
Site Reference ID/Investigator# 31134
Bruges, B-8310
Site Reference ID/Investigator# 31135
Bruges, B-8310
Site Reference ID/Investigator# 31233
Brussels, B-1000
Site Reference ID/Investigator# 31161
Brussels, B-1020
Site Reference ID/Investigator# 31223
Brussels, B-1030
Site Reference ID/Investigator# 31152
Brussels, B-1050
Site Reference ID/Investigator# 31251
Brussels, B-1081
Site Reference ID/Investigator# 31178
Brussels, B-1083
Site Reference ID/Investigator# 31236
Brussels, B-1090
Site Reference ID/Investigator# 31252
Brussels, B-1160
Site Reference ID/Investigator# 31117
Brussels, B-1180
Site Reference ID/Investigator# 31203
Brussels, B-1180
Site Reference ID/Investigator# 31232
Brussels, B-1200
Site Reference ID/Investigator# 31200
Brussels, B-1853
Site Reference ID/Investigator# 31129
Court-Saint-Étienne, B-1490
Site Reference ID/Investigator# 31244
Cuesmes, B-7033
Site Reference ID/Investigator# 31208
Damme, B-8340
Site Reference ID/Investigator# 31155
Dendermonde, B-9200
Site Reference ID/Investigator# 31197
Dendermonde, B-9200
Site Reference ID/Investigator# 31189
Diest, B-3290
Site Reference ID/Investigator# 31126
Dilbeek, B-1700
Site Reference ID/Investigator# 31116
Dworp, B-1653
Site Reference ID/Investigator# 31160
Dworp, B-1653
Site Reference ID/Investigator# 31179
Elingen, B-1671
Site Reference ID/Investigator# 31249
Embourg, B-4053
Site Reference ID/Investigator# 31166
Erpent, B-5101
Site Reference ID/Investigator# 31192
Esneux, B-4130
Site Reference ID/Investigator# 31188
Falmagne, B-5500
Site Reference ID/Investigator# 31195
Feluy, B-7181
Site Reference ID/Investigator# 31250
Floreffe, B-5150
Site Reference ID/Investigator# 31183
Genk, B-3600
Site Reference ID/Investigator# 31173
Genk-Waterschei, B-3600
Site Reference ID/Investigator# 31228
Ghent, B-9000
Site Reference ID/Investigator# 46502
Ghent, B-9000
Site Reference ID/Investigator# 31132
Gouy-Les-Pietons, B-6181
Site Reference ID/Investigator# 31124
Halle, B-1500
Site Reference ID/Investigator# 31191
Hamme, B-9220
Site Reference ID/Investigator# 31234
Hasselt, B-3510
Site Reference ID/Investigator# 31227
Heusy, B-4802
Site Reference ID/Investigator# 31212
Hofstade, B-1981
Site Reference ID/Investigator# 31143
Hove, B-2540
Site Reference ID/Investigator# 31226
Huy, B-4500
Site Reference ID/Investigator# 31119
Izegem, B-8870
Site Reference ID/Investigator# 31181
Izegem, B-8870
Site Reference ID/Investigator# 31149
Knokke, B-8300
Site Reference ID/Investigator# 31177
Koksijde, B-8670
Site Reference ID/Investigator# 31253
Kortrijk, B-8500
Site Reference ID/Investigator# 31130
Lasne, B-1380
Site Reference ID/Investigator# 31159
Lennik, B-1750
Site Reference ID/Investigator# 31123
Leper, B-8900
Site Reference ID/Investigator# 31241
Leper, B-8900
Site Reference ID/Investigator# 31255
Lesves, B-1380
Site Reference ID/Investigator# 31259
Leuven, 3000
Site Reference ID/Investigator# 31219
Libramont, B-6800
Site Reference ID/Investigator# 31128
Liège, B-4000
Site Reference ID/Investigator# 31144
Liège, B-4000
Site Reference ID/Investigator# 31185
Liège, B-4000
Site Reference ID/Investigator# 31207
Liège, B-4000
Site Reference ID/Investigator# 31245
Liège, B-4000
Site Reference ID/Investigator# 31224
Lier, B2400
Site Reference ID/Investigator# 31243
Lommel, B-3920
Site Reference ID/Investigator# 31225
Marcinelle, B-6001
Site Reference ID/Investigator# 31139
Mark, B-7850
Site Reference ID/Investigator# 31206
Mol, B-2400
Site Reference ID/Investigator# 31153
Mons, B-7000
Site Reference ID/Investigator# 31257
Mons, B-7000
Site Reference ID/Investigator# 31140
Mont-sur-Marchienne, B-6032
Site Reference ID/Investigator# 31222
Mortsel, B2640
Site Reference ID/Investigator# 31164
Namur, B-5000
Site Reference ID/Investigator# 31258
Nivelles, B-1400
Site Reference ID/Investigator# 31218
Oordegem, B-9340
Site Reference ID/Investigator# 31156
Oosterzele, B-9860
Site Reference ID/Investigator# 31214
Ostend, B-8400
Site Reference ID/Investigator# 31242
Ostend, B-8400
Site Reference ID/Investigator# 31131
Ottignies, B-1340
Site Reference ID/Investigator# 31163
Oudenaarde, B-9700
Site Reference ID/Investigator# 31125
Overijse, B-3090
Site Reference ID/Investigator# 31198
Pollinkhove, B-8647
Site Reference ID/Investigator# 31229
Ragnies, B-6532
Site Reference ID/Investigator# 31138
Rijmenam, B-2820
Site Reference ID/Investigator# 31122
Roeselare, B-8800
Site Reference ID/Investigator# 31174
Roeslare, B-8800
Site Reference ID/Investigator# 31136
Rotselaar, B-3110
Site Reference ID/Investigator# 31180
Rumbeke, B-8800
Site Reference ID/Investigator# 31157
Saint Truiden, B-3800
Site Reference ID/Investigator# 31150
Saint-Denis, B-7034
Site Reference ID/Investigator# 31215
Saint-Ghislain, B-7330
Site Reference ID/Investigator# 31176
Saintes, B-1480
Site Reference ID/Investigator# 31168
Schilde, B-2970
Site Reference ID/Investigator# 31220
Schoten, B-2900
Site Reference ID/Investigator# 31238
Schoten, B-2900
Site Reference ID/Investigator# 31142
Seneffe, B-7180
Site Reference ID/Investigator# 31158
Seraing, B-4100
Site Reference ID/Investigator# 31246
Silly, B-7830
Site Reference ID/Investigator# 31230
Sint-Genesius-Rode, B-1640
Site Reference ID/Investigator# 31240
Sint-Niklaas, B-9100
Site Reference ID/Investigator# 31120
Sint-Truiden, B-3800
Site Reference ID/Investigator# 31213
Sirault, B-7332
Site Reference ID/Investigator# 31182
Tielt, B-8700
Site Reference ID/Investigator# 31248
Tilff, B-4130
Site Reference ID/Investigator# 31151
Tournai, B-7500
Site Reference ID/Investigator# 31146
Tremelo, B-3120
Site Reference ID/Investigator# 31254
Uccle, B-1180
Site Reference ID/Investigator# 31256
Uccle, B-1180
Site Reference ID/Investigator# 31165
Veerle, B-2431
Site Reference ID/Investigator# 31193
Villers-Saint-Siméon, B-4453
Site Reference ID/Investigator# 31175
Wanze, B-4520
Site Reference ID/Investigator# 31145
Waregem, B-8790
Site Reference ID/Investigator# 31202
Wilrijk, B-2610
Site Reference ID/Investigator# 31201
Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, B-1150
Site Reference ID/Investigator# 31216
Xhendelesse, B-4652

Other trials in Belgium

Luxembourg4 sites

Site Reference ID/Investigator# 31221
Bascharage, L-4918
Site Reference ID/Investigator# 31172
Esch-sur-Alzette, L-4243
Site Reference ID/Investigator# 31162
Ettelbruck, L-9002
Site Reference ID/Investigator# 31231
Luxembourg, L-2540

Other trials in Luxembourg

About this study

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

Conditions: Prostatic Neoplasm
Being tested: leuprolide (Lucrin/Lucrin-Tri-depot)
Keywords: Multicenter study
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

leuprolide (Lucrin/Lucrin-Tri-depot)Drug
Also called Lucrin, Lucrin-Tri-depot
Subcutaneous or intramuscular administration for all participants

Study groups in NCT01081873
Study group	Role	What they receive
Advanced prostate cancer participants		Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment within local reimbursement guidelines. Receives: Drug: leuprolide (Lucrin/Lucrin-Tri-depot)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
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.
Measured: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
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.
Measured: month 3, and every 3 months until disease progression or up to 24 months, whichever came first
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.
Measured: time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first
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).
Measured: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first

Secondary outcomes (12)

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.
Measured: Baseline to disease progression or 24 months, whichever came first
Epidemiological Data: Mean Weight
The mean weight of all participants at baseline is provided.
Measured: at time 0 (Baseline)
Epidemiological Data: Mean Age
The mean age of all participants at baseline is provided.
Measured: at time 0 (Baseline)
Epidemiological Data: Race
The number of participants by race at baseline is presented.
Measured: at time 0 (Baseline)
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.
Measured: at time 0 (Baseline)
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.
Measured: at time 0 (Baseline)
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.
Measured: at time 0 (Baseline)
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.
Measured: at time 0 (Baseline)
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.
Measured: at time 0 (Baseline)
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.
Measured: at time 0 (Baseline)
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.
Measured: at time 0 (Baseline)
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.
Measured: at time 0 (Baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2004Dec 2010

First posted5 Mar 2010 (estimated)
Study startJun 2004
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 2,717 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01081873
Sponsor's protocol ID: PMOS-BELG-04-001
Status last verified: Oct 2012
First submitted: 27 Feb 2010
Last updated: 31 Oct 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Stage II Prostate Adenocarcinoma AJCC v7
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 1
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Advanced Prostate Cancer, Metastatic Prostate Cancer
RecruitingPhase 1
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer

All Prostatic Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01081873
Acronym / sponsor ID: PMOS-BELG-04-001
Conditions: Prostatic Neoplasm
Keywords: Multicenter study
Study type: Observational
Recruitment status: Completed
Enrolment: 2,717 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jun 2004
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 5 Mar 2010 (estimated)
Results: Posted 26 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Advanced prostate cancer participants	–	Drug: leuprolide (Lucrin/Lucrin-Tri-depot)Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment within local reimbursement guidelines.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Urologists

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
leuprolide (Lucrin/Lucrin-Tri-depot)Also: Lucrin, Lucrin-Tri-depotSubcutaneous or intramuscular administration for all participants	Drug	Advanced prostate cancer participants

Primary outcome

Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
Time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
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.
Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit
Time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.
Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit
Time frame: month 3, and every 3 months until disease progression or up to 24 months, whichever came first
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.
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
Time frame: time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first
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.
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.
Time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
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).

12 secondary outcomes

Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)
Time frame: Baseline to disease progression or 24 months, whichever came first
Epidemiological Data: Mean Weight
Time frame: at time 0 (Baseline)
Epidemiological Data: Mean Age
Time frame: at time 0 (Baseline)
Epidemiological Data: Race
Time frame: at time 0 (Baseline)
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.
Time frame: at time 0 (Baseline)
Epidemiological Data: PSA at Baseline
Time frame: at time 0 (Baseline)
Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.
Time frame: at time 0 (Baseline)
Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
Time frame: at time 0 (Baseline)
Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test
Time frame: at time 0 (Baseline)
Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.
Time frame: at time 0 (Baseline)
Epidemiological Data: Bone Scan at Baseline
Time frame: at time 0 (Baseline)
Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline
Time frame: at time 0 (Baseline)

Results and safety

Results posted to the registry on 26 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Advanced Prostate Cancer Participants	2,714	2,416

Primary outcome: Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit

Time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first. Number. Unit: participants

Measure	Advanced Prostate Cancer Participants at Baseline n = 1262	Advanced Prostate Cancer Participants at Month 3 n = 119	Advanced Prostate Cancer Participants at Month 6 n = 73	Advanced Prostate Cancer Participants at Month 9 n = 56	Advanced Prostate Cancer Participants at Month 12 n = 109	Advanced Prostate Cancer Participants at Month 15 n = 54	Advanced Prostate Cancer Participants at Month 18 n = 64	Advanced Prostate Cancer Participants at Month 21 n = 52	Advanced Prostate Cancer Participants at Month 24 n = 310	Advanced Prostate Cancer Participants - Last Available Record n = 1411
Absent	782	59	45	28	74	33	44	29	188	870
Local tumor	64	10	3	3	2	1	0	3	10	64
Single metastases	108	8	3	2	3	2	3	2	15	100
Multiple metastases in 1 organ	233	27	18	13	18	13	10	13	63	268
Multiple metastases in multiple organs	75	15	4	10	12	5	7	5	34	109

Population analysed: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

Primary outcome: Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit

Time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first. Mean (Standard Deviation). Unit: ng/mL

Measure	Advanced Prostate Cancer Participants at Baseline n = 2532	Advanced Prostate Cancer Participants at Month 3 n = 944	Advanced Prostate Cancer Participants at Month 6 n = 787	Advanced Prostate Cancer Participants at Month 9 n = 595	Advanced Prostate Cancer Participants at Month 12 n = 978	Advanced Prostate Cancer Participants at Month 15 n = 493	Advanced Prostate Cancer Participants at Month 18 n = 612	Advanced Prostate Cancer Participants at Month 21 n = 401	Advanced Prostate Cancer Participants at Month 24 n = 1661	Advanced Prostate Cancer Participants - Last Available Record n = 2595
Value	62.16 (282.64)	12.95 (88.03)	6.23 (34.27)	8.01 (43.28)	8.41 (52.84)	8.88 (44.66)	9.57 (57.42)	23.02 (141.92)	15.29 (129.06)	30.32 (183.21)

Population analysed: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

Primary outcome: Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit

Time frame: month 3, and every 3 months until disease progression or up to 24 months, whichever came first. Number. Unit: participants

Measure	Advanced Prostate Cancer Participants at Month 3 n = 1038	Advanced Prostate Cancer Participants at Month 6 n = 853	Advanced Prostate Cancer Participants at Month 9 n = 670	Advanced Prostate Cancer Participants at Month 12 n = 1031	Advanced Prostate Cancer Participants at Month 15 n = 565	Advanced Prostate Cancer Participants at Month 18 n = 679	Advanced Prostate Cancer Participants at Month 21 n = 475	Advanced Prostate Cancer Participants at Month 24 n = 1764	Advanced Prostate Cancer Participants - Last Available Record n = 2210
Complete response	525	496	402	668	347	401	276	1181	1420
Partial response	379	231	139	181	97	98	59	199	284
Stable disease	97	89	83	97	69	102	73	200	224
Progressive disease	37	37	46	85	52	78	67	184	282

Population analysed: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

Primary outcome: 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

Time frame: time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first. Number. Unit: participants

Measure	Advanced Prostate Cancer Participants at Baseline n = 2128	Advanced Prostate Cancer Participants at Month 3 n = 941	Advanced Prostate Cancer Participants at Month 6 n = 752	Advanced Prostate Cancer Participants at Month 9 n = 604	Advanced Prostate Cancer Participants at Month 12 n = 881	Advanced Prostate Cancer Participants at Month 15 n = 509	Advanced Prostate Cancer Participants at Month 18 n = 593	Advanced Prostate Cancer Participants at Month 21 n = 426	Advanced Prostate Cancer Participants at Month 24 n = 1495	Advanced Prostate Cancer Participants - Last Available Record n = 2365
> 10 years	395	132	100	91	113	75	82	66	206	331
5 - 10 years	1041	476	402	320	479	276	309	225	805	1173
1 - 5 years	663	312	237	180	268	140	182	117	420	735
6 - 12 months	26	15	10	11	18	15	13	12	48	93
< 6 months	3	6	3	2	3	3	7	6	16	33

Population analysed: Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Advanced Prostate Cancer Participants	121 of 2,714 (4.5%)	8 of 2,714 (0.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Simonne Lens study director

Abbott

135 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasm, run by Abbott at 135 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in Belgium, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit (time frame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01081873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.