Study on Preserving Erectile Function in Intermediate Risk Prostate Cancer Treatment

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04025372

Provider View

This clinical trial is exploring a new hormonal therapy combined with radiation to treat intermediate risk prostate cancer. The study aims to see if this new treatment is as effective as the standard therapy while also preserving erectile function.

Patient Parameters

Program Overview

The purpose of this study is to compare a new hormonal therapy, called Darolutamide, with the standard hormone therapy when used with radiation for treating intermediate risk prostate cancer. Researchers want to find out if Darolutamide can provide the same level of cancer control as the current treatments while helping to maintain erectile function. Darolutamide works by blocking testosterone signals in the body, which can help weaken prostate cancer cells. The study will also monitor erectile function before, during, and after treatment to see if it can be preserved without affecting long-term cancer control.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment. The study is investigating whether Darolutamide, a new form of hormonal therapy, can be as effective as the current standard treatments for intermediate risk prostate cancer when combined with radiation therapy. Darolutamide blocks testosterone signals, which can help weaken prostate cancer cells. Although it has shown promise in more advanced prostate cancer, its effectiveness in intermediate risk prostate cancer is still unknown. The standard treatments for this type of cancer include radiation therapy with or without hormone therapy, or surgery. Hormone therapy usually involves medications that reduce testosterone levels, which can help weaken cancer cells and make them more susceptible to radiation. The study will also assess erectile function at different stages of treatment to determine if it can be preserved without compromising cancer control.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer confirmed by a biopsy within the last year.
  • Classified as intermediate risk prostate cancer based on specific medical criteria.
  • Able to undergo radiation therapy aimed at curing the cancer.
  • Aged 18 or older.
  • Have good organ function based on recent blood tests.
  • Have good erectile function as assessed by a specific questionnaire.
  • Agree to use effective birth control methods during the study and for three months after the last dose of the study drug.
  • Able to understand and follow study procedures and provide written consent.
  • Able to swallow pills.
  • Prostate size must be less than 90 cc as determined by imaging tests.

Exclusion Criteria

  • Previous treatments for prostate cancer, such as surgery or certain types of hormone therapy.
  • Previous use of specific medications that affect hormone levels.
  • Previous radiation therapy that would overlap with current treatment areas.
  • Presence of cancer that has spread to lymph nodes or other parts of the body.
  • Use of erectile aids other than certain oral medications.
  • History of severe heart conditions or other serious health issues.
  • Uncontrolled high blood pressure.
  • History of other cancers that are currently being treated or have a high risk of returning.
  • Allergic reactions to similar drugs used in the study.
  • Any condition that would prevent participation in the study, as determined by the study doctor.

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