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RecruitingLast updated: 15 May 2024

ANZadapt: This phase II study is investigating whether taking hormone therapy (abiraterone or enzalutamide) continuously or periodically is more effective at treating metastatic castration-resistant prostate cancerANZadapt: Phase II Randomised Controlled Trial of Patient-specific Adaptive Versus Continuous Abiraterone or eNZalutamide in Metastatic Castration-resistant Prostate Cancer

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will start taking abiraterone or enzalutamide (AA/ENZ) daily. Each participant's prostate-specific antigen (PSA) levels will be tested monthly and once PSA has dropped to >50% they will stop treatment. The treatment will remain paused until PSA levels have risen again above the pre-treatment baseline. Once PSA levels decline >50% again, treatment will again be paused. This cycle will continue until criteria for treatment failure have been met. In the Active Comparator Arm, participants will receive standard continuous treatment with abiraterone or enzalutamide (AA/ENZ) daily until criteria for treatment failure are met.

Conditions

This trial is treating patients with castration-resistant prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

ANZadapt

More information

Trial Identifiers

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Trial sponsor

Leiden University Medical Center,Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Scientific Title

ANZadapt: Phase II Randomised Controlled Trial of Patient-specific Adaptive Versus Continuous Abiraterone or eNZalutamide in Metastatic Castration-resistant Prostate Cancer

Eligibility

Inclusion

  1. Willing and able to provide informed consent;
  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/L)); 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 ≥10 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

  1. Life-threatening or serious medical or psychiatric illness that could, in investigator's opinion, potentially interfere with participation in this study;
  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.

Inclusion

  • Your cancer has spread to other parts of the body.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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