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

NCT02077634 | Completed Phase 2 DMC

• 2 other identifiers: SPARE-001AUO study number
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 22

Brief Summary

This is an exploratory Phase 2 multicenter, randomized, open-label study with a randomization allocation ratio of 1:1 \[abiraterone acetate + prednisone + LHRH-therapy (Arm A) versus abiraterone acetate + prednisone (Arm B)\]. 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

Outcome Measures

Primary Outcomes (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).

  12 month

Secondary Outcomes (3)

• Correlation of radiographic-progression-free survival with early PSA-response

  12 month

• Hormonal analyses

  12 month

• Adverse Events

  12 month

Study Arms (2)

abiraterone acetate + prednisone + LHRH-therapy

ACTIVE COMPARATOR

Patients randomized to this group will continue their LHRH-therapy.

Drug: abiraterone acetate + prednisone + LHRH-therapy

abiraterone acetate + prednisone

ACTIVE COMPARATOR

Patients randomized to this group will stop LHRH-therapy.

Drug: abiraterone acetate + prednisone

Interventions

abiraterone acetate + prednisone + LHRH-therapy DRUG

Hormon therapy will go on

abiraterone acetate + prednisone + LHRH-therapy

abiraterone acetate + prednisone DRUG

ormon therapy will be stopped

abiraterone acetate + prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (22)

Gemeinschaftspraxis für Onkologie

Augsburg, 86150, Germany

Location

Gemeinschaftspraxis für Urologie

Berlin, 13187, Germany

Location

Urologie Bonn-Rhein-Sieg, Praxis Bad Godesberg

Bonn, 53177, Germany

Location

Praxisgemeinschaft für Urologie

Borken, 46325, Germany

Location

Facharztpraxis Dr. Klier, Cologne-Study-Group

Cologne, 50968, Germany

Location

Urologicum Duisburg

Duisburg, 47179, Germany

Location

Urologicum Hamburg

Hamburg, 22399, Germany

Location

Universitätsklinikum Homburg/Saar, Klinik für Urologie und Kinderurologie

Homburg/Saar, 66421, Germany

Location

Urologische Gemeinschaftspraxis

Kempen, 47906, Germany

Location

Klinikum Landshut

Landshut, 84034, Germany

Location

Urologisches Zentrum Lübeck (UZL)

Lübeck, 23560, Germany

Location

Gemeinschaftspraxis PUR-R

Mülheim, 45468, Germany

Location

Gemeinschaftspraxis Urologie Pasing

München, 81241, Germany

Location

Privatärztliche urologische Studienpraxis

Nürtingen, 72622, Germany

Location

Pandamed - Übag

Remscheid, 42853, Germany

Location

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

Rostock, 18107, Germany

Location

Praxisgemeinschaft für Onkologie und Urologie

Wilhelmshaven, 26389, Germany

Location

Praxisgemeinschaft

Wolfsburg, 38440, Germany

Location

DGU

Wuppertal, 42103, Germany

Location

Pandamed - Übag

Wuppertal, 42103, Germany

Location

Praxis für Urologie

Würselen, 52146, Germany

Location

Praxis für Urologie

Zwickau, 08060, Germany

Location

Related Publications (1)

• 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.

  PMID: 28978327 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Study Officials

• Carsten-Henning Ohlmann, PD Dr.

  University Hospital, Saarland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: March 4, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

DE (22)