Study on Modulating Adenosine Signaling and Immune Checkpoint Inhibition in Hormone Sensitive Prostate Cancer with Limited Spread

Sponsor: Catherine Spina

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05915442

Provider View

This clinical trial is testing a combination of study drugs and radiation therapy to see if they can improve outcomes for men with hormone-sensitive prostate cancer that has spread to a few areas. The study aims to find out if this approach can better control the cancer and delay the need for hormone therapy.

Patient Parameters

Program Overview

The study is exploring a new treatment approach for men with prostate cancer that has spread to a few areas (oligometastatic) and is still sensitive to hormone therapy. It combines three study drugs—zimberelimab, etrumadenant, and quemliclustat—with targeted radiation therapy to see if this combination can improve cancer control and delay progression compared to radiation therapy alone. The study will measure various outcomes, including cancer progression, response to treatment, and safety.

Description

This study focuses on men with prostate cancer that has spread to a limited number of sites and is still responsive to hormone therapy. With advancements in imaging technology, doctors can now better identify and target these limited metastases. The study aims to enhance the effectiveness of stereotactic body radiation therapy (SBRT) by adding drugs that target specific pathways involved in cancer growth and immune suppression.

The treatment involves using zimberelimab, an immune checkpoint inhibitor, along with etrumadenant and quemliclustat, which target the adenosine signaling pathway. These drugs are combined with SBRT to see if they can improve cancer control, delay progression, and reduce the need for hormone therapy. The study will assess various outcomes, including cancer progression, response to treatment, and safety.

Participants will be monitored for changes in prostate-specific antigen (PSA) levels, local cancer control, progression-free survival, and overall treatment response. The study will also evaluate the safety and tolerability of the treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Men with confirmed prostate cancer.
  • Primary prostate cancer treated with surgery and/or radiation, with or without hormone therapy.
  • Have 1 to 3 small, asymptomatic metastatic tumors in bone or soft tissue that developed in the last 6 months.
  • PSA levels between 0.5 and 50 ng/mL.
  • PSA doubling time less than 15 months.
  • Testosterone levels above 125 ng/mL.
  • Aged 18 years or older.
  • Life expectancy greater than 12 months.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Normal organ and bone marrow function based on specific blood tests.
  • Male participants with female partners of childbearing potential must use effective contraception.
  • Willingness to sign informed consent and comply with study requirements.

Exclusion Criteria

  • Previous systemic therapy, except for specific hormone therapy related to primary prostate cancer treatment.
  • Known brain metastases.
  • Spinal cord compression or risk of compression.
  • Large lung or liver metastases.
  • History of other cancers within the last 2 years, except for certain low-risk cancers.
  • Use of other investigational treatments.
  • Recent use of certain antibiotics or inability to swallow medications.
  • Severe bleeding or lung conditions.
  • Recent severe infections or positive hepatitis B test without follow-up negative DNA test.
  • Use of certain medications that interact with study drugs.
  • Immunosuppression or active viral infections.
  • Active autoimmune disease or uncontrolled illnesses.
  • Inability to undergo required imaging or radiation therapy.
  • Recent use of live vaccines.
  • Refusal to sign informed consent.

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