Study on Personalized PSA-Triggered Management for Androgen-Sensitive Prostate Cancer

Inclusion Criteria

Cohort A Eligibility (Step 1 Registration)

• Must be 18 years or older.
• Have hormone-sensitive prostate cancer confirmed by lab tests, without small cell cancer type.
• Cancer has spread to other parts of the body, confirmed by scans.
• Baseline testosterone level over 50 ng/dl before starting treatment for metastatic cancer.
• PSA level of 1 ng/mL or higher.
• General health status allowing participation in standard treatment with relugolix and ARPI.
• If sexually active with a partner who can become pregnant, must use effective birth control and agree to use condoms during intercourse.
• Must not donate sperm during the study and for 3 months after the last treatment.
• Any side effects from previous cancer treatments must be resolved or stable.
• Must have a smartphone and be able to use study-specific apps.
• Must be able to understand and sign a consent form.

Cohort A Eligibility (Step 2 Registration)

• PSA level of 0.2 ng/mL or lower after 6-12 months of treatment with relugolix and androgen receptor pathway inhibitors.

Cohort B Eligibility

• Must be 18 years or older.
• Have hormone-sensitive prostate cancer confirmed by lab tests, without small cell cancer type.
• Cancer has spread to other parts of the body, confirmed by scans.
• PSA level of 0.2 ng/mL or lower after treatment with hormone therapy or androgen receptor pathway inhibitors.
• General health status allowing participation in standard treatment with relugolix and ARPI.
• If sexually active with a partner who can become pregnant, must use effective birth control and agree to use condoms during intercourse.
• Must not donate sperm during the study and for 3 months after the last treatment.
• Must have a smartphone and be able to use study-specific apps.
• Must be able to understand and sign a consent form.

Exclusion Criteria

Cohort A Eligibility (Step 1 Registration)

• Previously received hormone therapy or surgical castration for metastatic prostate cancer.
• Have another cancer that could affect safety or participation.
• Have untreated or unstable brain metastases.
• Have uncontrolled illness or infection that could affect participation.
• Have medical or mental conditions that affect understanding or participation.
• Have severe allergies to study medications.
• Taking medications not allowed in the study.

Cohort A Eligibility (Step 2 Registration)

• Receiving other cancer treatments for prostate cancer.
• Cancer has progressed to a more resistant form.
• Have another cancer that could affect safety or participation.
• Taking medications not allowed in the study.

Cohort B Eligibility

• Receiving other cancer treatments for prostate cancer.
• Have had surgical castration.
• Have another cancer that could affect safety or participation.
• Have untreated or unstable brain metastases.
• Have uncontrolled illness or infection that could affect participation.
• Have medical or mental conditions that affect understanding or participation.
• Have severe allergies to study medications.
• Taking medications not allowed in the study.