Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005987

Trial Description

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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)

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Trial Acronym

SPARE

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005987
  •   2014/03/20
  •   2013/12/09
  •   yes
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Secondary IDs

  •   NCT02077634  (ClinicalTrials.gov)
  •   SPARE-001/AP 67/11  (Association of Urogenital Oncology (AUO))
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: abiraterone acetate + prednisone + LHRH-therapy
  •   Drug: abiraterone acetate + prednisone
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- 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).

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/05/31
  •   70
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Association of Urogenital Oncology (AUO)
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    •   [---]*
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    • University Hospital, Saarland
    • Carsten-Henning Ohlmann, PD Dr. 
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    • Heidrun G Rexer 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/07/17


* This entry means the parameter is not applicable or has not been set.