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AzTrials

Prostate CancerPhase 2SPARENCT02077634

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

A Phase 2 study testing abiraterone acetate + prednisone + LHRH-therapy and abiraterone acetate + prednisone in people with Prostate Cancer, run by Universität des Saarlandes at 22 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)]. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
abiraterone acetate + prednisone + LHRH-therapy and abiraterone acetate + prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
22 sitesGermany
Study dates
May 2014to 1 Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Germany22 sites

  • Gemeinschaftspraxis für Onkologie

    Augsburg, 86150

  • Gemeinschaftspraxis für Urologie

    Berlin, 13187

  • Urologie Bonn-Rhein-Sieg, Praxis Bad Godesberg

    Bonn, 53177

  • Praxisgemeinschaft für Urologie

    Borken, 46325

  • Facharztpraxis Dr. Klier, Cologne-Study-Group

    Cologne, 50968

  • Urologicum Duisburg

    Duisburg, 47179

  • Urologicum Hamburg

    Hamburg, 22399

  • Universitätsklinikum Homburg/Saar, Klinik für Urologie und Kinderurologie

    Homburg/Saar, 66421

  • Urologische Gemeinschaftspraxis

    Kempen, 47906

  • Klinikum Landshut

    Landshut, 84034

  • Urologisches Zentrum Lübeck (UZL)

    Lübeck, 23560

  • Gemeinschaftspraxis PUR-R

    Mülheim, 45468

  • Gemeinschaftspraxis Urologie Pasing

    München, 81241

  • Privatärztliche urologische Studienpraxis

    Nürtingen, 72622

  • Pandamed - Übag

    Remscheid, 42853

  • Zentrum für Onkologie und Urologie Rostock, Wissenschaftskontor Nord GmbH & Co. KG

    Rostock, 18107

  • Praxisgemeinschaft für Onkologie und Urologie

    Wilhelmshaven, 26389

  • Praxisgemeinschaft

    Wolfsburg, 38440

  • DGU

    Wuppertal, 42103

  • Pandamed - Übag

    Wuppertal, 42103

  • Praxis für Urologie

    Würselen, 52146

  • Praxis für Urologie

    Zwickau, 08060

Other trials in Germany

About this study

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)

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.

Conditions
Prostate Cancer
Being tested
abiraterone acetate + prednisone + LHRH-therapy, abiraterone acetate + prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abiraterone acetate + prednisone + LHRH-therapyDrug

    Hormon therapy will go on

  • abiraterone acetate + prednisoneDrug

    ormon therapy will be stopped

Study groups in NCT02077634
Study groupRoleWhat they receive
abiraterone acetate + prednisone + LHRH-therapyActive comparatorPatients randomized to this group will continue their LHRH-therapy.
Receives: Drug: abiraterone acetate + prednisone + LHRH-therapy
abiraterone acetate + prednisoneActive comparatorPatients randomized to this group will stop LHRH-therapy.
Receives: Drug: abiraterone acetate + prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 month

Secondary outcomes (3)

  1. 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

    Measured: 12 month

  2. Hormonal analyses

    To investigate effects of both treatment arms on hormones of the pituitary gonadal axis

    Measured: 12 month

  3. Adverse Events

    To characterize the safety profile of abiraterone acetate while sparing LHRH-therapy in comparison to continuing LHRH-therapy

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2014 (estimated)
  2. Study startMay 2014
  3. Primary completion1 Apr 2019
  4. Study completion1 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077634
Sponsor's protocol ID
SPARE-001
Other IDs
AUO study number
Acronym
SPARE
Status last verified
Mar 2020
First submitted
9 Dec 2013
Last updated
18 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28978327

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing abiraterone acetate + prednisone + LHRH-therapy and abiraterone acetate + prednisone in people with Prostate Cancer, run by Universität des Saarlandes at 22 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

radiographic-progression-free survival (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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