TESTOSTERONE for Metastatic castration-resistant prostate cancer

Inclusion criteria

• {"criterion_text":"- Ability to understand and willingness to sign a written informed consent form (ICF) document\n- Acceptable liver function: •Bilirubin ≤ institutional upper limit of normal (ULN) •aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < 1.5 times ULN\n- Acceptable renal function: •Serum creatinine < 2.0 times ULN\n- Acceptable hematologic status: •Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L) •Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L) •Hemoglobin ≥ 9 g/dL\n- At least 4 weeks since prior radiation\n- Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and their female partners of child-bearing potential to use a method of highly effective birth control during treatment and for 6 months thereafter\n- Eastern Cooperative Oncology Group Performance status (ECOG PS) grade ≤2\n- Men ≥18 years\n- Histologically-confirmed adenocarcinoma of the prostate\n- Treatment with continuous androgen ablative therapy (either surgical castration or luteinizing hormone-releasing hormone (LHRH)-agonist/antagonist) in combination with an ARI (Apalutamide, Darolutamide, or Enzalutamide, as currently approved for mCSPC)\n- Documented castrate level of serum testosterone (<50 ng/dl)\n- Metastatic disease radiographically documented by CT/MRI, bone scan or PSMA-PET-CT\n- Disease progression while on Apalutamide, Darolutamide or Enzalutamide as currently approved based on: PSA progression defined as an over 25% increase in PSA, as determined within two consecutive measurements separated by at least one week and/or Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions, or PCWG3 for patients with bone disease\n- Screening PSA ≥ 1.0 ng/mL"}

Exclusion criteria

• {"criterion_text":"- Pain due to metastatic prostate cancer > NRS 3 and/or requiring opioid treatment\n- Major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, or patients not fully recovered from prior surgery (i.e., unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate\n- Known BRCA-mutations\n- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs\n- Long QT-syndrome\n- Thrombophilia\n- Migraine\n- History of seizures\n- Prior malignancy, except prostate cancer, adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer (pTa) or cancer for which treatment has been completed ≥ 5 years before randomization and from which the participant has been disease-free\n- Brain metastases\n- Current participation in any other clinical trial or use of any other IMP within the last 30 days prior to screening visit or within 5 half-lives of the IMP (whichever is longer) and throughout the trial\n- Prior systemic treatment for mCRPC\n- Any dependent relationship of the subject with the investigator, trial site or sponsor/sponsor’s delegate (e.g., employees or relatives)\n- Institutionalization because of legal or regulatory order\n- Visceral metastases and/or evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g., femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, progression on first line antihormonal therapy within 6 months)\n- Any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)\n- Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study\n- Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or C\n- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule\n- Prior history of a thromboembolic event within the last 12 months that is not being treated with systemic anticoagulation\n- Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical treatment"}

Primary endpoints

• {"endpoint_text":"- PFS defined as time from randomization to biochemical, clinical, or radiographic progression, or death from any cause, whichever occurs first.","definition_or_measurement_approach":"PFS defined as time from randomization to biochemical, clinical, or radiographic progression, or death from any cause."}
• {"endpoint_text":"- QoL until progression measured using the German version of the FACIT-F scale","definition_or_measurement_approach":"Quality of life measured using the German version of the FACIT-F scale until progression."}

Secondary endpoints

• {"endpoint_text":"- 50% PSA response (PSA50) defined as a PSA decrease of ≥ 50% at any time compared to baseline value","definition_or_measurement_approach":"PSA50: PSA decrease of ≥50% at any time compared to baseline."}
• {"endpoint_text":"- Percentage of change in PSA from baseline to 12 weeks","definition_or_measurement_approach":"Percent change in PSA from baseline to week 12."}
• {"endpoint_text":"- Maximum decline in PSA that occurs at any point after start of treatment","definition_or_measurement_approach":"Maximum observed PSA decline from baseline at any time on treatment."}
• {"endpoint_text":"- Symptomatic progression-free survival defined as time from randomization to clinical progression or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Time from randomization to clinical progression or death from any cause."}
• {"endpoint_text":"- Overall Survival (OS) defined as time from randomization to death from any cause","definition_or_measurement_approach":"Time from randomization to death from any cause."}

Germany

Earliest CTIS Part Ii Submission Date

14-07-2025

Latest Decision Or Authorization Date

24-07-2025

Processing Time Days

10

Number Of Sites

5

Number Of Participants

60

Primary sponsor

Full Name

Universitaet Muenster

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"Bayer Vital GmbH","duties_or_roles":"Source of monetary support","organisation_type":""}