Actively Recruiting
Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC
Led by Leiden University Medical Center · Updated on 2024-11-26
168
Participants Needed
19
Research Sites
260 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
A
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hormone tablets, abiraterone (Zytiga®) and enzalutamide (Xtandi®) are approved to treat advanced prostate cancer. However, even if these drugs are helpful, their effectiveness usually diminishes over time. Small pilot studies have indicated that using hormone tablets sparingly, for just long enough to control the cancer, followed by a break in treatment and restarting them later, seems to improve how long hormone tablets can control the cancer. This study aims to find out if this pause/restart strategy is better than taking hormone tablets every day continuously. The study will include 168 people with metastatic castrate resistant prostate cancer in the Netherlands and Australia. Patients will be randomly 1:1 assigned between the control group and the experimental group. In the control group, patients will take the treatment with AA/ENZ every day until the prostate cancer doesn't respond anymore to the treatment. In the experimental group, patients will start with daily AA/ENZ until the PSA has declined for \>50%. The treatment will then be paused and monthly PSA measurements will be performed. The treatment will be re-initiated when the PSA has increased to the level of before starting treatment. The treatment will be continued daily until the PSA has again dropped for \>50%. This pause/restart cycle will be repeated until the prostate cancer doesn't respond anymore to the treatment.
CONDITIONS
Official Title
Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Aged 18 or older
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Receiving ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy with testosterone at screening C=1.7 nmol/L (<0.5 ng/mL)
- Presence of metastatic disease on whole body bone scan and/or CT scan
- Progressive disease at study entry defined by PCWG3 criteria while on ADT
- PSA concentration of E=2 ng/mL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Controlled symptoms with stable opioids for cancer-related pain for more than 4 weeks and no urgent need for radiotherapy
- Estimated life expectancy of at least 12 months
- Availability and consent to share archival prostate cancer tissue or willingness to undergo new tumor biopsy
- Adequate organ function including specified blood counts and liver and kidney function
- Discontinuation of other therapies for CRPC (except denosumab and bisphosphonates) at least 3 weeks prior to randomization
- Ability to swallow study drug and comply with study requirements
You will not qualify if you...
- Life-threatening or serious medical or psychiatric illness interfering with study participation
- Diagnosis or treatment for another systemic malignancy within 2 years before first dose (except certain fully resected skin and bladder cancers)
- Known or suspected brain metastases or leptomeningeal disease
- Small-cell or neuroendocrine differentiation of prostate cancer
- Radiation therapy to primary tumor within 3 weeks of screening
- Radiation or radionuclide therapy for metastasis within 3 weeks of screening, except for pain relief
- History of uncontrolled seizures if treated with enzalutamide
- Unstable heart conditions including ischemic heart disease, arrhythmias, or Class III/IV heart failure
- Known HIV infection or active chronic hepatitis B or C
- Known gastrointestinal disease affecting drug absorption or tolerance
- Prior treatments with CYP17 inhibitors or novel androgen receptor inhibitors (except allowed docetaxel in certain settings)
- Any condition that interferes with participation or safety as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Border Medical Oncology Research Unit / The Border Cancer Hospital
Albury, New South Wales, Australia, 2460
Actively Recruiting
2
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
3
St George Hospital
Kogarah, New South Wales, Australia
Actively Recruiting
4
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Actively Recruiting
5
Genesis Care North Shore
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
6
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Actively Recruiting
7
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Actively Recruiting
8
Mater Hospital Brisbane
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
9
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
10
ICON Cancer Centre
Adelaide, South Australia, Australia
Actively Recruiting
11
Eastern Health Box Hill
Box Hill, Victoria, Australia
Actively Recruiting
12
Fiona Stanly Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
13
Radboud Univeristy Medical Centre
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
14
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands, 2134 TM
Actively Recruiting
15
Isala Ziekenhuis
Zwolle, Overijssel, Netherlands, 8025 AB
Actively Recruiting
16
Groene Hart Ziekenhuis
Gouda, South Holland, Netherlands, 2803 HH
Actively Recruiting
17
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
18
Meander Medical Centre
Amersfoort, Utrecht, Netherlands, 3813 TZ
Actively Recruiting
19
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
T
Tom van der Hulle, MD PhD
CONTACT
S
Samantha Oakes, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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