DECREASE / TROG 19.06

1) ≥ 18 years of age and provided written Informed Consent.

2) Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.

3) Castration-resistant prostate cancer, defined as at least 2 consecutive PSA rises obtained at least 1 week apart in the setting of castrate testosterone levels.

4) Castrate level of serum testosterone (<1.7 nmol/l [50 ng/dl]) on gonadotrophin – releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy.

5) A baseline PSA level of at least 1ng per millilitre and a PSA doubling time of 10 months or less.

6) Adequate bone marrow reserve and organ function Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

7) At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions; At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions:
|— a) Local recurrence within the prostate gland or prostate bed.
|— b) Regional lymph node disease (below the aortic bifurcation).
|— c) Extra-pelvic lymph node, bone or soft tissue metastatic disease.

1) Patients with detectable metastases or a history of metastatic disease on conventional imaging.

2) Prior treatment with second-generation androgen receptor (AR) antagonists, CYP17 enzyme inhibitors or oral ketoconazole.

3) Use of oestrogens or 5-α reductase inhibitors or anti-androgens within 28 days before randomisation.

4) Use of systemic corticosteroid with a dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomisation.

5) Radiotherapy within 12 weeks prior to randomisation.

6) Initiation of treatment with an osteoclast-targeted therapy to prevent skeletal-related events within 12 weeks before randomisation.

7) Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.

8) Uncontrolled hypertension.

9) Prior malignancy.

10) Gastrointestinal disorder or procedure that expects to interfere significantly with the absorption of study treatment.

11) Unable to swallow study medications and comply with study requirements.

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