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)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	abiraterone acetate + prednisone + LHRH-therapy	Hormon therapy will go on
DRUG	abiraterone acetate + prednisone	ormon therapy will be stopped

Timeline

• Start date: 2014-05-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2014-03-04
• Last updated: 2020-03-18

Locations

22 sites across 1 country: Germany