- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02077634
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)
March 17, 2020 updated by: Universität des Saarlandes
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Augsburg, Germany, 86150
- Gemeinschaftspraxis für Onkologie
-
Berlin, Germany, 13187
- Gemeinschaftspraxis für Urologie
-
Bonn, Germany, 53177
- Urologie Bonn-Rhein-Sieg, Praxis Bad Godesberg
-
Borken, Germany, 46325
- Praxisgemeinschaft für Urologie
-
Duisburg, Germany, 47179
- Urologicum Duisburg
-
Hamburg, Germany, 22399
- Urologicum Hamburg
-
Homburg/Saar, Germany, 66421
- Universitätsklinikum Homburg/Saar, Klinik für Urologie und Kinderurologie
-
Kempen, Germany, 47906
- Urologische Gemeinschaftspraxis
-
Köln, Germany, 50968
- Facharztpraxis Dr. Klier, Cologne-Study-Group
-
Landshut, Germany, 84034
- Klinikum Landshut
-
Lübeck, Germany, 23560
- Urologisches Zentrum Lübeck (UZL)
-
Mülheim/Ruhr, Germany, 45468
- Gemeinschaftspraxis PUR-R
-
München, Germany, 81241
- Gemeinschaftspraxis Urologie Pasing
-
Nürtingen, Germany, 72622
- Privatärztliche urologische Studienpraxis
-
Remscheid, Germany, 42853
- Pandamed - Übag
-
Rostock, Germany, 18107
- Zentrum für Onkologie und Urologie Rostock, Wissenschaftskontor Nord GmbH & Co. KG
-
Wilhelmshaven, Germany, 26389
- Praxisgemeinschaft für Onkologie und Urologie
-
Wolfsburg, Germany, 38440
- Praxisgemeinschaft
-
Wuppertal, Germany, 42103
- DGU
-
Wuppertal, Germany, 42103
- Pandamed - Übag
-
Würselen, Germany, 52146
- Praxis für Urologie
-
Zwickau, Germany, 08060
- Praxis für Urologie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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:
- Serum bilirubin <1.5 x ULN (except for patients with documented Gilbert's disease)
- AST or ALT <2.5 x ULN
- 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:
- Surgical castration (i.e. orchiectomy).
- 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.
- Patients receiving a 6- or 12-months formulation of LHRH-therapy
- Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid.
- Pathological finding consistent with small cell carcinoma of the prostate
- Liver or visceral organ metastasis
- Known brain metastasis
- 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.
- Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
- Radiation therapy for treatment of the primary tumour within 6 weeks of Cycle 1, Day 1
- Radiation or radionuclide therapy for treatment of metastatic CRPC
- Prior treatment with Abiraterone acetate or other CYP17 inhibitors (ketoconazole, TAK700, TOK001) ), Enzalutamide (Xtandi) or investigational agents targeting the androgen receptor for prostate cancer for more than 7 days
- Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
- 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)
- 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)
- 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
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- 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
- Any condition that requires treatment with Digoxin, digitoxin, and other digitalis drugs
- Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
- Other malignancy with a ≥30 % probability of recurrence within 24 months, except non- melanoma skin cancer.
- Administration of an investigational therapy within 30 days of Cycle 1, Day 1
- Any condition, which, in the opinion of the investigator, would preclude participation in this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: abiraterone acetate + prednisone + LHRH-therapy
Patients randomized to this group will continue their LHRH-therapy.
|
Hormon therapy will go on
|
Active Comparator: abiraterone acetate + prednisone
Patients randomized to this group will stop LHRH-therapy.
|
ormon therapy will be stopped
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 month
|
Hormonal analyses
Time Frame: 12 month
|
To investigate effects of both treatment arms on hormones of the pituitary gonadal axis
|
12 month
|
Adverse Events
Time Frame: 12 month
|
To characterize the safety profile of abiraterone acetate while sparing LHRH-therapy in comparison to continuing LHRH-therapy
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carsten-Henning Ohlmann, PD Dr., University Hospital, Saarland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
March 3, 2014
First Posted (Estimate)
March 4, 2014
Study Record Updates
Last Update Posted (Actual)
March 18, 2020
Last Update Submitted That Met QC Criteria
March 17, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Prednisone
- Abiraterone Acetate
Other Study ID Numbers
- SPARE-001
- AUO study number (Other Identifier: AP 67/11)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
NRG OncologyNational Cancer Institute (NCI)RecruitingProstate Adenocarcinoma | Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
Clinical Trials on abiraterone acetate + prednisone + LHRH-therapy
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingMetastatic Castration-Resistant Prostate Cancer (mCRPC)Korea, Republic of, United States, Spain, France, Belgium, China, Taiwan, United Kingdom, Australia, Czechia, Hungary, Poland, Russian Federation
-
Janssen Research & Development, LLCCompletedProstate NeoplasmsCanada, France, Poland, Ukraine, United Kingdom, China, Belgium, Spain, Argentina, Colombia, Israel, Mexico, Portugal, Bulgaria, Germany, Malaysia, Romania, South Africa, Turkey, Korea, Republic of, Japan, Australia, Netherlands, Sweden, New Zealand and more
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingHigh-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
-
University Health Network, TorontoCompletedCastration-resistant Prostate CancerCanada
-
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator...Active, not recruitingProstate CancerUnited States
-
ExelixisTerminatedProstatic Neoplasms | Prostate Cancer | Castration Resistant Prostate CancerUnited States
-
Janssen Research & Development, LLCCompletedProstate CancerChina, Malaysia, Russian Federation, Thailand
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Millennium: The Takeda Oncology CompanyCompletedRecurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate CancerUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Terminated
-
Janssen Research & Development, LLCCompletedPostmenopausal | Metastatic ER+ Her2- Breast CancerUnited States, France, Ukraine, United Kingdom, Belgium, Spain, Netherlands, Korea, Republic of, Russian Federation, Poland, Luxembourg, Ireland