Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC

PHASE2RecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

November 10, 2022

Primary Completion Date

November 10, 2027

Study Completion Date

November 10, 2027

Conditions
Prostatic Neoplasms, Castration-Resistant
Interventions
OTHER

Patient-specific adaptive therapy

Patients will start taking abiraterone or enzalutamide (AA/ENZ) daily. PSA will be measured every month as well as radiological evaluation by CT-scan and bone scan. Treatment will be continued until PSA has dropped \>50%. The treatment will then be paused. Once the PSA has risen again above the pretreatment baseline, treatment will be re-initiated. AA/ENZ will be stopped again after the PSA declines \>50% from the baseline. This will be continued until criteria for treatment failure are met (death by any cause or at least 2 out of 3 of the following events while on treatment: radiographic progression on CT-scan and/or bone scan, PSA progression or clinical progression).

DRUG

Abiraterone acetate

Use of abiraterone or enzalutamide

DRUG

Enzalutamide

Use of abiraterone or enzalutamide

Trial Locations (19)

2050

RECRUITING

Chris O'Brien Lifehouse, Camperdown

2065

RECRUITING

Genesis Care North Shore, St Leonards

2076

RECRUITING

Sydney Adventist Hospital, Wahroonga

2298

RECRUITING

Calvary Mater Newcastle, Newcastle

2460

RECRUITING

Border Medical Oncology Research Unit / The Border Cancer Hospital, Albury

4101

RECRUITING

Mater Hospital Brisbane, South Brisbane

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

6150

RECRUITING

Fiona Stanly Hospital, Murdoch

Unknown

RECRUITING

St George Hospital, Kogarah

RECRUITING

Sunshine Coast University Hospital, Birtinya

RECRUITING

ICON Cancer Centre, Adelaide

RECRUITING

Eastern Health Box Hill, Box Hill

6525 GA

RECRUITING

Radboud Univeristy Medical Centre, Nijmegen

2134 TM

RECRUITING

Spaarne Gasthuis, Hoofddorp

8025 AB

RECRUITING

Isala Ziekenhuis, Zwolle

2803 HH

RECRUITING

Groene Hart Ziekenhuis, Gouda

2333 ZA

RECRUITING

Leids Universitair Medisch Centrum, Leiden

3813 TZ

RECRUITING

Meander Medical Centre, Amersfoort

9713 GZ

RECRUITING

University Medical Center Groningen, Groningen

All Listed Sponsors
collaborator

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

OTHER

collaborator

Anticancer Fund, Belgium

OTHER

lead

Leiden University Medical Center

OTHER