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Trial of Abiraterone Acetate Plus LHRH-therapy Versus Abiraterone Acetate Sparing LHRH-therapy in Patients With Progressive Chemotherapy-naïve Castration-resistant Prostate Cancer (SPARE) (SPARE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Association of Urogenital Oncology (AUO)
Sponsor:
Information provided by (Responsible Party):
Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier:
NCT02077634
First received: December 9, 2013
Last updated: November 3, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Prostate Cancer
Drug: abiraterone acetate + prednisone + LHRH-therapy
Drug: abiraterone acetate + prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase-II Trial of Abiraterone Acetate Plus LHRH-therapy Versus Abiraterone Acetate Sparing LHRH-therapy in Patients With Progressive Chemotherapy-naïve Castration-resistant Prostate Cancer (SPARE)

Resource links provided by NLM:


Further study details as provided by Association of Urogenital Oncology (AUO):

Primary Outcome Measures:
  • radiographic-progression-free survival [ Time Frame: 12 month ]
    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).


Secondary Outcome Measures:
  • Correlation of radiographic-progression-free survival with early PSA-response [ Time Frame: 12 month ]
    To establish additional clinically relevant information regarding early PSA responses to abiraterone and to correlate these with radiographic-progression free survival

  • Hormonal analyses [ Time Frame: 12 month ]
    To investigate effects of both treatment arms on hormones of the pituitary gonadal axis

  • Adverse Events [ Time Frame: 12 month ]
    To characterize the safety profile of abiraterone acetate while sparing LHRH-therapy in comparison to continuing LHRH-therapy


Estimated Enrollment: 70
Study Start Date: May 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: abiraterone acetate + prednisone + LHRH-therapy
Patients randomized to this group will continue their LHRH-therapy.
Drug: abiraterone acetate + prednisone + LHRH-therapy
Hormon therapy will go on
Active Comparator: abiraterone acetate + prednisone
Patients randomized to this group will stop LHRH-therapy.
Drug: abiraterone acetate + prednisone
ormon therapy will be stopped

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent
  2. Written Data Protection Consent has been obtained
  3. Male aged 18 years and above
  4. Histologically or cytologically confirmed adenocarcinoma of the prostate
  5. 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
  6. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
  7. 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.
  8. Medically castrated, with testosterone levels of <20-50 ng/dl (< 2.0 nM).
  9. 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).
  10. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2 (Appendix 6)
  11. Hemoglobin ≥9.0 g/dL independent of transfusion
  12. Platelet count ≥100,000 /μl
  13. Serum albumin ≥3.0 g/dl
  14. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥60 ml/min (Appendix 7)
  15. Serum potassium ≥3.5 mmol/l
  16. Liver function:

    1. Serum bilirubin <1.5 x ULN (except for patients with documented Gilbert's disease)
    2. AST or ALT <2.5 x ULN
  17. Able to swallow the study drug whole as a tablet
  18. Life expectancy of at least 6 months
  19. 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:

  1. Surgical castration (i.e. orchiectomy).
  2. Application of any LHRH-therapy (LHRH-analogue or LHRH-antagonist) within 3 months (for patients receiving a 3-months formulation) or 1 months (for patients receiving a 1-month formulation) prior to Cycle 1 day 1.
  3. Patients receiving a 6- or 12-months formulation of LHRH-therapy
  4. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  5. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid.
  6. Pathological finding consistent with small cell carcinoma of the prostate
  7. Liver or visceral organ metastasis
  8. Known brain metastasis
  9. Use of opiate analgesics for cancer-related pain, including codeine, tramadol, tilidin and others (see Appendix 9), currently or anytime within 4 weeks of Cycle 1 Day 1.
  10. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
  11. Radiation therapy for treatment of the primary tumour within 6 weeks of Cycle 1, Day 1
  12. Radiation or radionuclide therapy for treatment of metastatic CRPC
  13. Prior treatment with Abiraterone acetate or other CYP17 inhibitors (ketoconazole, TAK700, TOK001) or investigational agents targeting the androgen receptor for prostate cancer for more than 7 days
  14. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
  15. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
  16. Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day1)
  17. Uncontrolled hypertension (systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg). Patients with a history of hypertension are allowed provided that blood pressure is controlled by anti- hypertensive treatment
  18. Active or symptomatic viral hepatitis or chronic liver disease
  19. History of pituitary or adrenal dysfunction
  20. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of <50 % at baseline
  21. Any condition that requires treatment with Digoxin, digitoxin, and other digitalis drugs
  22. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
  23. Other malignancy with a ≥30 % probability of recurrence within 24 months, except non- melanoma skin cancer.
  24. Administration of an investigational therapy within 30 days of Cycle 1, Day 1
  25. Any condition, which, in the opinion of the investigator, would preclude participation in this trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02077634

Contacts
Contact: Heidrun G Rexer 0049+39827/79 677 SPARE@MeckEvidence.de
Contact: Carsten-Henning Ohlmann, PD Dr. 0049+6841/16- ext 24 777 carsten.ohlmann@uniklinikum-saarland.de

Locations
Germany
Gemeinschaftspraxis für Onkologie Active, not recruiting
Augsburg, Germany, 86150
Gemeinschaftspraxis für Urologie Recruiting
Berlin, Germany, 13187
Contact: Roger Zillman, Dipl.-Med.    030/485-38 68      
Urologie Bonn-Rhein-Sieg, Praxis Bad Godesberg Active, not recruiting
Bonn, Germany, 53177
Praxisgemeinschaft für Urologie Recruiting
Borken, Germany, 46325
Contact: Christoph Rüssel, Dr.    02861/58 62      
Urologicum Duisburg Recruiting
Duisburg, Germany, 47179
Contact: Eva Hellmis, Dr.    0203/50 03 04-0      
Urologicum Hamburg Recruiting
Hamburg, Germany, 22399
Contact: Henrik Suttmann, Dr.    040/69 21 44-0      
Universitätsklinikum Homburg/Saar, Klinik für Urologie und Kinderurologie Recruiting
Homburg/Saar, Germany, 66421
Contact: Carsten-Henning Ohlmann, PD Dr.    06841-16-24700      
Urologische Gemeinschaftspraxis Recruiting
Kempen, Germany, 47906
Contact: Jan Marin, Dr.    02152/89 92-90      
Facharztpraxis Dr. Klier, Cologne-Study-Group Recruiting
Köln, Germany, 50968
Contact: Jörg Klier, Dr.    0221/36 20-25      
Gemeinschaftspraxis Urologie Pasing Active, not recruiting
München, Germany, 81241
Pandamed - Übag Active, not recruiting
Remscheid, Germany, 42853
Zentrum für Onkologie und Urologie Rostock, Wissenschaftskontor Nord GmbH & Co. KG Recruiting
Rostock, Germany, 18107
Contact: Andreas Hübner, Dr.    0381/76 01-704      
DGU Recruiting
Wuppertal, Germany, 42103
Contact: Jochen Gleissner, Dr.    0202/24 80 60      
Pandamed - Übag Recruiting
Wuppertal, Germany, 42103
Contact: Johannes Dahm    0202/44 81 05      
Praxis für Urologie Recruiting
Zwickau, Germany, 08060
Contact: Michael Scheffler, Dr.    0375/56 09 460      
Sponsors and Collaborators
Association of Urogenital Oncology (AUO)
Investigators
Principal Investigator: Carsten-Henning Ohlmann, PD Dr. University Hospital, Saarland
  More Information

Responsible Party: Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier: NCT02077634     History of Changes
Other Study ID Numbers: SPARE-001/AP 67/11
Study First Received: December 9, 2013
Last Updated: November 3, 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on March 23, 2017