Phase II pre-operative study of ‘super-castration’ with combination Degarelix, Abiraterone, Bicalutamide and Prednisone in high-risk localized prostate cancer.

Phase II neo-adjuvant study of ‘super-castration’ with combination Degarelix, Abiraterone, Bicalutamide and Prednisone in high-risk localized prostate cancer to assess effects on complete pathological response rates.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000772842

Enrollment

Registered

2012-07-20

Start date

2012-10-18

Completion date

2014-03-05

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to evaluate the safety and efficacy of combination Degarelix, Abiraterone, Bicalutamide and Prednisolone in high-risk localised prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have confirmed prostate cancer which is suitable for radical prostatectomy with curative intent. Trial details All participants in this trial will be treated with 'super castration' triple therapy. This involves taking the medications Degarelix, Bicalutamide, Abiraterone and Prednisone for a period of 6 months prior to radical prostatectomy. Participants will be assessed at regular intervals in order to determine the safety, tolerability and response rate to treatment when compared with historically treated patients.

Interventions

This is an open label phase II trial in the neo-adjuvant setting. After signing informed consent, patients will be treated with ‘supercastration’ triple therapy (degarelix 240/80 mg subcutaneously once a month, bicalutamide 50 mg orally once a day, abiraterone 1000 mg orally once a day, prednisone 5 mg orally once a day) for a period of 6 months prior to radical prostatectomy.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histologically confirmed prostate cancer, present in at least 2 biopsy cores, associated with one of the following features: PSA >20 ng/ml, predominant cancer Gleason pattern 4 or above (Gleason 4+3=7, 8-10), clinical stage >/= T2c. ECOG 0-1 Otherwise suitable for radical prostatectomy with curative intent. Normal organ and marrow function.

Exclusion criteria

Metastatic disease. Previous systemic therapy for prostate cancer. Previous local therapy for prostate cancer (radiotherapy, HIFU, cryotherapy) History of liver disease or baseline bilirubin >/= 1.5 X ULN or Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >/=2.5 X ULN Uncontrolled hypertension Clinically significant cardiac disease History of pituitary or adrenal dysfunction Hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL

Outcome results