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| ID | Type | Description | Link |
|---|---|---|---|
| 7054IL/0025 |
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| Name | Class |
|---|---|
| Scandinavian Prostate Cancer Group | NETWORK |
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The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide | Drug | 150mg p.o. daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Throughout study period | |
| Time to clinical progression | Throughout study period |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability in terms of adverse events and laboratory parameters | Throughout study period | |
| Time to treatment failure | Throughout study period | |
| Prostate-specific antigen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Iversen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aalborg | Denmark | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26681677 | Derived | Thomsen FB, Brasso K, Berg KD, Gerds TA, Johansson JE, Angelsen A, Tammela TL, Iversen P; Scandinavian Prostate Cancer Group. Association between PSA kinetics and cancer-specific mortality in patients with localised prostate cancer: analysis of the placebo arm of the SPCG-6 study. Ann Oncol. 2016 Mar;27(3):460-6. doi: 10.1093/annonc/mdv607. Epub 2015 Dec 17. | |
| 22129214 |
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| Placebo |
| Drug |
|
| Initial study period up to 2005 amended protocol |
| Charlottenlund |
| Denmark |
| Research Site | Copenhagen | Denmark |
| Research Site | Esbjerg | Denmark |
| Research Site | Frederiksberg | Denmark |
| Research Site | Frederikssund | Denmark |
| Research Site | Glostrup Municipality | Denmark |
| Research Site | Herlev | Denmark |
| Research Site | Holbuk | Denmark |
| Research Site | NYK BING Falster | Denmark |
| Research Site | Odense | Denmark |
| Research Site | Orhus | Denmark |
| Research Site | Randers | Denmark |
| Research Site | S Nderborg | Denmark |
| Research Site | Helsinki | Finland |
| Research Site | Joensuu | Finland |
| Research Site | Kokkola | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Lahti | Finland |
| Research Site | Lappeenranta | Finland |
| Research Site | OYS (oulu) | Finland |
| Research Site | Tampere | Finland |
| Research Site | Turku | Finland |
| Research Site | Bergen | Norway |
| Research Site | BODU | Norway |
| Research Site | Drammen | Norway |
| Research Site | Fredrikstad | Norway |
| Research Site | Harstad | Norway |
| Research Site | Kristiansand | Norway |
| Research Site | Lesund | Norway |
| Research Site | Levanger | Norway |
| Research Site | Lillehammer | Norway |
| Research Site | Oslo | Norway |
| Research Site | Porsgrunn | Norway |
| Research Site | Rud | Norway |
| Research Site | Stavanger | Norway |
| Research Site | Strummen | Norway |
| Research Site | Tromsu | Norway |
| Research Site | Trondheim | Norway |
| Research Site | Tunsberg | Norway |
| Research Site | Gothenburg | Sweden |
| Research Site | Govle | Sweden |
| Research Site | Helsingborg | Sweden |
| Research Site | Hudiksvall | Sweden |
| Research Site | Junkoping | Sweden |
| Research Site | Kristinehamn | Sweden |
| Research Site | Luleå | Sweden |
| Research Site | Malmu | Sweden |
| Research Site | Norrköping | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Urebro | Sweden |
| Research Site | Ustersund | Sweden |
| Research Site | VoSTEROS | Sweden |
| Research Site | Vostervik | Sweden |
| Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81. doi: 10.1111/j.1464-410X.2010.09319.x. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
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