Actively Recruiting
Phase II Randomised Controlled Trial of Patient-specific Adaptive Versus Continuous Abiraterone or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Led by Leiden University Medical Center · Updated on 2024-11-26
168
Participants Needed
19
Research Sites
N/A
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
Researchers are studying metastatic castration-resistant prostate cancer, focusing on how to best use hormone tablets abiraterone and enzalutamide. These drugs are commonly used but tend to become less effective over time. The study is evaluating whether pausing and restarting the treatment based on PSA levels, rather than continuous daily use, can better control the cancer and delay resistance. This phase II randomized trial includes 168 men from the Netherlands and Australia to compare these two approaches. Participants will be randomly assigned to one of two groups. In the control group, patients take abiraterone or enzalutamide daily without breaks until the cancer stops responding. In the experimental group, patients begin daily treatment until their PSA level drops by more than 50%, then pause treatment. Monthly PSA tests are done, and treatment restarts when PSA rises to the pre-treatment level. This pause and restart cycle continues until treatment failure or disease progression. Both groups have regular CT scans and bone scans to monitor the cancer. During the study, participants will have PSA measured every four weeks, and radiographic scans every 12 weeks for up to three years. Clinical progression and adverse events will be tracked regularly. Quality of life and pain will be assessed through questionnaires every 12 weeks. The main measure is the time until treatment failure, defined as death or cancer progression. Follow-up will continue for up to two years after treatment ends to assess survival and skeletal events.
CONDITIONS
Brief 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
- On ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy with testosterone at screening ≤1.7 nmol/L (<0.5 ng/mL)
- Presence of metastatic disease on bone scan and/or CT scan
- Progressive disease on androgen deprivation therapy defined by rising PSA levels or radiographic progression
- PSA concentration of ≥2 ng/mL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Controlled symptoms with stable opioid use for cancer-related pain and no urgent radiotherapy needed
- Estimated life expectancy of ≥12 months
- Availability of archival prostate cancer tissue or willingness to undergo biopsy
- Adequate organ function including specified blood counts and liver/kidney tests
- Discontinuation of other therapies for castration-resistant prostate cancer (excluding denosumab and bisphosphonates) at least 3 weeks before randomization
- Able to swallow study drug and comply with study requirements
You will not qualify if you...
- Life-threatening or serious medical or psychiatric illness that could interfere with study participation
- Diagnosis or treatment for another systemic cancer within 2 years except certain skin or bladder cancers fully resected
- Known or suspected brain metastases or leptomeningeal disease
- Small-cell or neuroendocrine prostate cancer differentiation
- Radiation therapy for primary tumor within 3 weeks prior to screening
- Radiation or radionuclide therapy for metastases within 3 weeks prior to screening, except for pain relief
- History of uncontrolled seizures if treated with enzalutamide
- Unstable heart disease, arrhythmias, or severe heart failure
- Known HIV infection or active chronic hepatitis B or C
- Gastrointestinal disease affecting absorption or tolerance of study drugs
- Prior treatment with CYP17 inhibitors or novel androgen receptor inhibitors except certain allowed drugs
- Any condition deemed by investigator to place patient at undue risk or interfere with safety data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years or until treatment failure
Participants receive either patient-specific adaptive therapy where treatment with abiraterone or enzalutamide is paused and restarted based on PSA levels, or continuous treatment with these drugs until treatment failure criteria are met.
Monthly visits for PSA measurement and every 12 weeks for radiographic evaluations
Duration - Up to 2 years after end of treatment
Participants are monitored for overall survival and other outcomes after treatment ends.
Visits every 6 months
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
S
Samantha Oakes, Prof.
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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