Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC
NCT ID: NCT05393791
Last Updated: 2024-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
168 participants
INTERVENTIONAL
2022-11-10
2027-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
In the experimental group, treatment will be paused if there is a \>50% decline in baseline PSA. AA/ENZ will be restarted if the PSA rises to the same level or higher than the pre-treatment PSA. AA/ENZ treatment will be paused again after the PSA declines \>50% from the baseline. This pause/restart cycle of adaptive therapy will be repeated presuming consent, tolerance and safety. Patients who do not have a \>50% decline of their baseline PSA level after restarting AA/ENZ remain on treatment until the criteria for treatment failure are met.
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).
Abiraterone acetate
Use of abiraterone or enzalutamide
Enzalutamide
Use of abiraterone or enzalutamide
Control group
In the control group, patients will receive the standard continuous treatment with abiraterone or enzalutamide (AA/ENZ) until criteria for treatment failure are met.
Abiraterone acetate
Use of abiraterone or enzalutamide
Enzalutamide
Use of abiraterone or enzalutamide
Interventions
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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).
Abiraterone acetate
Use of abiraterone or enzalutamide
Enzalutamide
Use of abiraterone or enzalutamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged 18 or older;
3. Histologically or cytologically confirmed adenocarcinoma of the prostate;
4. Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e. surgical or medical castration with testosterone at screening ≤1.7 nmol/L (\<0.5 ng/mL)); patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
5. Presence of metastatic disease on WBBS and/or CT-scan;
6. Progressive disease at study entry defined as per PCWG3 as one or more of the following criteria that occurred while the patient was on ADT:
1. PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥4 weeks since last flutamide or ≥6 weeks since last bicalutamide or nilutamide); OR
2. Radiographic PD on bone scintigraphy and/or CT-scan;
7. A PSA concentration of ≥2 ng/mL.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
9. Controlled symptoms (opioids for cancer related pain stable for \>4 weeks, no need for urgent radiotherapy for symptomatic lesions);
10. Estimated life expectancy of ≥12 months;
11. Patient has archival prostate cancer tissue available and which he consents to share or is willing to undergo a new tumour biopsy;
12. Adequate organ function: absolute neutrophil count \> 1,500/μL (\> 1.5\*109/L); platelet count \> 100,000/μL (\> 100\*109/L), haemoglobin \> 90 g/L; total bilirubin \< 1.5 times ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 times ULN; creatinine \< 175 μmol/L; albumin \> 30 g/L;
13. Any other therapies for CRPC (excluding denosumab and bisphosphonates) have to be discontinued 3 weeks prior to study randomisation;
14. Able to swallow the study drug and comply with study requirements.
Exclusion Criteria
2. Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs. Potential participants with non-melanoma skin cancer, non-muscle invasive bladder cancer, or carcinoma in situ of any type are allowed if they have undergone complete resection;
3. Known or suspected brain metastasis or leptomeningeal disease;
4. Small-cell or neuroendocrine differentiation of prostate cancer;
5. Radiation therapy for treatment of the primary tumour within 3 weeks of screening visit;
6. Radiation or radionuclide therapy for treatment of metastasis within 3 weeks of screening visit, excluding radiation to reduce pain symptoms;
7. History of uncontrolled seizures (if patient and investigator wish to choose treatment with enzalutamide)
8. Unstable symptomatic ischemic heart disease, ongoing arrhythmias or New York Heart Association (NYHA) Class III or IV heart failure;
9. Known HIV infection, active chronic hepatitis B or C;
10. Known gastrointestinal (GI) disease that could interfere with GI absorption/tolerance of study drugs;
11. Prior treatments with CYP17 inhibitors (e.g. ketoconazole) or novel androgen receptor inhibitors (e.g. abiraterone, apalutamide, darolutamide or enzalutamide). Bicalutamide and nilutamide should be stopped \>6 weeks before screening visit. Prior treatment with docetaxel in the mHSPC setting is allowed.
12. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
18 Years
MALE
No
Sponsors
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Australian and New Zealand Urogenital and Prostate Cancer Trials Group
OTHER
Anticancer Fund, Belgium
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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dr. Tom van der Hulle
Principal Investigator
Principal Investigators
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Tom van der Hulle, MD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
A/Prof. Craig Gedye, MBChB,FRACP
Role: STUDY_CHAIR
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Dr. Laurence Krieger, MBChB,FRACP
Role: PRINCIPAL_INVESTIGATOR
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Dr. Amy Rieborn
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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Border Medical Oncology Research Unit / The Border Cancer Hospital
Albury, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Genesis Care North Shore
St Leonards, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
ICON Cancer Centre
Adelaide, South Australia, Australia
Eastern Health Box Hill
Box Hill, Victoria, Australia
Fiona Stanly Hospital
Murdoch, Western Australia, Australia
Radboud Univeristy Medical Centre
Nijmegen, Gelderland, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
Isala Ziekenhuis
Zwolle, Overijssel, Netherlands
Groene Hart Ziekenhuis
Gouda, South Holland, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Meander Medical Centre
Amersfoort, Utrecht, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANZUP 2101
Identifier Type: OTHER
Identifier Source: secondary_id
79835
Identifier Type: -
Identifier Source: org_study_id
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