Australian Clinical Trials

Broad Health Condition Metastatic Hormone Naive Prostate Cancer

Specific Health Condition

Trial FocusTreatment

Recruitment Details

Recruitment status
Recruiting

Recruitment State
NSW,QLD,SA,VIC,

Hospital
St Vincent's Hospital Sydney
Royal Brisbane and Women's Hospital
Royal Adelaide Hospital

Phase of TrialPhase 2

Trial summary

This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy
followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with
newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).

Key inclusion criteria

Inclusion Criteria for study registration:

    1. Patient has provided written informed consent

    2. Male aged 18 years or older at screening

    3. Prostate cancer diagnosed within 12 weeks of commencement of screening

    4. Histologically or cytologically confirmed adenocarcinoma of the prostate without
       significant neuroendocrine differentiation or small cell histology OR metastatic
       disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or
       para-aortic lymph nodes) with a rising serum PSA

    5. Evidence of metastatic disease on CT and/or bone scan

    6. PSA > 10ng/ml prior to commencement of medical ADT or surgical orchidectomy

    7. Adequate haematological, renal and hepatic functions as defined by:

         -  Absolute neutrophil count >1.5 x 109/L

         -  Platelet count >100 x 109/L

         -  Haemoglobin = 90g/L (no red blood cell transfusion in 4 weeks prior to
            randomisation)

         -  Creatinine Clearance = 40mL/min (Cockcroft-Gault formula)

         -  Total bilirubin < 1.5 x ULN (unless known or suspected Gilbert syndrome)

         -  Aspartate transaminase (AST) or alanine transaminase (ALT) = 2.0 x ULN (or = 5.0
            x ULN in the presence of liver metastases)

    8. Have a performance status of 0-2 on the ECOG Performance Scale (see Appendix 1)

    9. Life expectancy greater than 6 months with treatment

   10. Assessed by a medical oncologist as suitable for treatment with docetaxel

   11. Patients must agree to use an adequate method of contraception

   12. Willing and able to comply with all study requirements, including all treatments and
       required assessments including follow-up

  Exclusion Criteria for Registration:

    1. Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate
       cancer. The following exceptions are permitted:

         -  Up to 4 weeks of ADT with luteinising hormone releasing hormone agonists or
            antagonists or orchiectomy ± concurrent anti-androgens are permitted prior to
            commencement of screening. At investigator discretion, patients may start ADT at
            commencement of protocol therapy

         -  Up to one course of palliative radiation or surgical therapy to treat symptoms
            resulting from metastatic disease if it was administered at least 14 days prior
            to registration

    2. Symptomatic cord compression, or clinical or imaging findings concerning for impending
       cord compression

    3. Central nervous system metastases

    4. Patients with Sjogren's syndrome

    5. Has a history or current evidence of any condition, therapy, or laboratory abnormality
       that might confound the results of the trial, interfere with the patient's
       participation for the full duration of the trial, or is not in the best interest of
       the patient to participate, in the opinion of the treating investigator

    6. Prior diagnosis of another cancer that was:

         -  More than 3 years prior to current diagnosis with subsequent evidence of disease
            recurrence or clinical expectation of recurrence greater than 10%

         -  Within 3 years of current diagnosis with the exception of successfully treated
            basal cell or squamous cell skin carcinoma or adequately treated non-muscle
            invasive bladder cancer (Tis, Ta and low grade T1 tumours)

  Inclusion Criteria for Randomisation:

    1. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined after central review as a
       minimum uptake of SUVmax 15 at a site of disease

    2. High-volume metastatic disease on 68Ga-PSMA PET/CT defined as visceral metastases or =
       4 bone metastases with = 1 outside the vertebral column and pelvis (extra-axial
       skeleton)

    3. Patient continues to meet all the inclusion criteria for registration

  Exclusion Criteria for Randomisation:

    1. Major FDG-PET discordance defined as presence of FDG positive disease with minimal
       PSMA expression in multiple sites (>5) or in more than 50% of total disease volume

    2. All the exclusion criteria for registration continue to not apply

Minimum age18 Years

GenderMale

Can Healthy volunteers participate? No