We share your goals

The INTREPId Study aims to find better ways to help men beat prostate cancer and continue enjoying their lives to the fullest.

INTREPId is exploring a new hormonal therapy which may, in conjunction with radiation, effectively treat prostate cancer while preserving erectile function. This new therapy, called darolutamide, has proved effective in more advanced forms of prostate cancer. The INTREPId Study will investigate its effect on intermediate risk prostate cancer.

The study is innovative in its utilization of a validated genomic risk classifier to tailor the intensity of patients’ radiation therapy. The genomic classifier is currently the most accurate method for evaluating how aggressive the cancer is.

Who can join

To be eligible, participants must be:

  • Diagnosed with intermediate-risk prostate cancer (Gleason 7 and/or PSA 10-20 and/or clinical T2b/T2c)
  • Currently experiencing good erectile function
  • Willing to wait up to 4 weeks for obtaining a genomic risk classification
  • Able to have radiation treatment
  • Able to swallow pills
  • Able to come to one of the study’s sites once a month
  • Pre-treatment (never had any treatment for prostate cancer, i.e. surgery, hormone therapy, chemotherapy, etc.)
  • Willing to be randomized to receive either standard treatment or the new treatment that is being tested

If you’re interested in joining the study, you will be screened for eligibility. If you are interested in participating in the INTREPId Study, please email: intrepid@dfci.harvard.edu

What’s required

Men who join the study will be randomly assigned (by chance, like flipping a coin) to one of two groups.

  • One group will receive “standard of care,” which is radiation and standard of care hormonal therapy by injection.
  • The other group will receive radiation and an alternative hormonal therapy, darolutamide. The goal of this study is to evaluate whether darolutamide can preserve erectile function without sacrificing cancer control.

Before you begin treatment, tissue from your recent biopsy will be genetically analyzed. This may take up to four weeks.

Participants will receive hormone therapy treatment for six months, in addition to receiving radiation treatment as determined by their radiation oncologist.

After completing treatment, you or your physician will be contacted every 6 months for 3 years. This may be done by clinic visit, phone call, or email.

You will also receive quality-of-life questionnaires and memory exams approximately every 12 months for 3 years.

Risks and benefits

Study participation is completely voluntary. Your decision to participate or not will not affect your medical care.

Being in the INTREPId Study may not benefit you directly. By participating, you’ll be partnering with researchers who are looking for new ways to help men with prostate cancer. What we learn may contribute to advances in prostate cancer treatment and help people in the future.

Risks of participating in this study are about the same as the possible risks of your treatment if you weren’t in the study.

All participant data will be kept confidential, and no information that could identify anyone will appear in any publications.