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| ID | Type | Description | Link |
|---|---|---|---|
| AUO study number | Other Identifier | AP 67/11 |
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This is an exploratory Phase 2 multicenter, randomized, open-label study with a randomization allocation ratio of 1:1 [abiraterone acetate + prednisone + LHRH-therapy (Arm A) versus abiraterone acetate + prednisone (Arm B)]. For both groups patients will receive a dose of 1000 mg abiraterone acetate and 10mg prednisone daily (QD). Study drug will be administered as 4 x 250-mg abiraterone acetate tablets and prednisone will be administered as 5 mg orally twice a day (BID). Patients randomized to the LHRH-therapy group will receive the same LHRH-therapy they received prior to entering the trial. 70 medically castrated male patients with metastatic CRPC who have shown tumor progression and are non- or mildly-symptomatic will be enrolled from approximately 12 German study sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abiraterone acetate + prednisone + LHRH-therapy | Active Comparator | Patients randomized to this group will continue their LHRH-therapy. |
|
| abiraterone acetate + prednisone | Active Comparator | Patients randomized to this group will stop LHRH-therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abiraterone acetate + prednisone + LHRH-therapy | Drug | Hormon therapy will go on |
|
| Measure | Description | Time Frame |
|---|---|---|
| radiographic-progression-free survival | The primary objective of the study is to analyze the clinical benefit of abiraterone acetate plus prednisone while sparing LHRH-therapy in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC). | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of radiographic-progression-free survival with early PSA-response | To establish additional clinically relevant information regarding early PSA responses to abiraterone and to correlate these with radiographic-progression free survival | 12 month |
| Hormonal analyses |
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Inclusion Criteria:
Willing and able to provide written informed consent
Written Data Protection Consent has been obtained
Male aged 18 years and above
Histologically or cytologically confirmed adenocarcinoma of the prostate
Metastatic disease documented by positive CT/MRI and/or bone scan (both must be performed). If lymph node metastasis is the only evidence of metastasis, it must be ≥2 cm in diameter
Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 for the question of worst pain within last 24 hours (Appendix 8) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic.
Medically castrated, with testosterone levels of <20-50 ng/dl (< 2.0 nM).
Combined androgen blockade is permitted, but not required. If patients received combined androgen blockade with an anti-androgen they must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (≥4 weeks since last flutamide, ≥6 weeks since last bicalutamide or nilutamide).
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2 (Appendix 6)
Hemoglobin ≥9.0 g/dL independent of transfusion
Platelet count ≥100,000 /μl
Serum albumin ≥3.0 g/dl
Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥60 ml/min (Appendix 7)
Serum potassium ≥3.5 mmol/l
Liver function:
Able to swallow the study drug whole as a tablet
Life expectancy of at least 6 months
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last study drug administration.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carsten-Henning Ohlmann, PD Dr. | University Hospital, Saarland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemeinschaftspraxis für Onkologie | Augsburg | 86150 | Germany | |||
| Gemeinschaftspraxis für Urologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28978327 | Derived | Ohlmann CH, Jaschke M, Jaehnig P, Krege S, Gschwend J, Rexer H, Stockle M. Abiraterone acetate plus LHRH therapy versus abiraterone acetate while sparing LHRH therapy in patients with progressive, metastatic and chemotherapy-naive, castration-resistant prostate cancer (SPARE): study protocol for a randomized controlled trial. Trials. 2017 Oct 4;18(1):457. doi: 10.1186/s13063-017-2195-x. |
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| abiraterone acetate + prednisone | Drug | ormon therapy will be stopped |
|
To investigate effects of both treatment arms on hormones of the pituitary gonadal axis |
| 12 month |
| Adverse Events | To characterize the safety profile of abiraterone acetate while sparing LHRH-therapy in comparison to continuing LHRH-therapy | 12 month |
| Berlin |
| 13187 |
| Germany |
| Urologie Bonn-Rhein-Sieg, Praxis Bad Godesberg | Bonn | 53177 | Germany |
| Praxisgemeinschaft für Urologie | Borken | 46325 | Germany |
| Facharztpraxis Dr. Klier, Cologne-Study-Group | Cologne | 50968 | Germany |
| Urologicum Duisburg | Duisburg | 47179 | Germany |
| Urologicum Hamburg | Hamburg | 22399 | Germany |
| Universitätsklinikum Homburg/Saar, Klinik für Urologie und Kinderurologie | Homburg/Saar | 66421 | Germany |
| Urologische Gemeinschaftspraxis | Kempen | 47906 | Germany |
| Klinikum Landshut | Landshut | 84034 | Germany |
| Urologisches Zentrum Lübeck (UZL) | Lübeck | 23560 | Germany |
| Gemeinschaftspraxis PUR-R | Mülheim | 45468 | Germany |
| Gemeinschaftspraxis Urologie Pasing | München | 81241 | Germany |
| Privatärztliche urologische Studienpraxis | Nürtingen | 72622 | Germany |
| Pandamed - Übag | Remscheid | 42853 | Germany |
| Zentrum für Onkologie und Urologie Rostock, Wissenschaftskontor Nord GmbH & Co. KG | Rostock | 18107 | Germany |
| Praxisgemeinschaft für Onkologie und Urologie | Wilhelmshaven | 26389 | Germany |
| Praxisgemeinschaft | Wolfsburg | 38440 | Germany |
| DGU | Wuppertal | 42103 | Germany |
| Pandamed - Übag | Wuppertal | 42103 | Germany |
| Praxis für Urologie | Würselen | 52146 | Germany |
| Praxis für Urologie | Zwickau | 08060 | Germany |
| 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 |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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