Study on Nivolumab for Patients with High-Risk Recurrent Prostate Cancer
Sponsor: Beth Israel Deaconess Medical Center
ClinicalTrials ID:NCT03637543
This clinical trial is exploring the use of an immune-based drug called Nivolumab to treat prostate cancer that has returned after initial treatment. The study aims to determine if Nivolumab can help manage prostate cancer by boosting the immune system's ability to fight the disease.
Patient Parameters
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Program Overview
This study is testing Nivolumab, an immune-based drug, to see if it can help treat prostate cancer that has come back after surgery or radiation. Nivolumab works by blocking a pathway that may allow the immune system to better recognize and attack cancer cells. Although it is not yet approved for prostate cancer, it has been used for other types of cancer. Researchers are investigating if using Nivolumab earlier in the disease process, before hormone therapies, could be more effective.
Description
This is a Phase II clinical trial, which means it is testing the safety and effectiveness of Nivolumab for treating prostate cancer that has returned after initial treatment. Nivolumab is an investigational drug for this specific use, meaning it is still being studied and not yet approved by the FDA for prostate cancer. The drug is known to block a pathway that may help the immune system recognize and fight cancer cells.
The study focuses on patients who have a rising PSA level after surgery or radiation for prostate cancer. Researchers are interested in seeing if Nivolumab can have a greater effect when used earlier in the disease course, before patients start hormone therapies. This trial will help determine if Nivolumab can be a viable treatment option for patients with high-risk recurrent prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Must have signed an informed consent form to participate.
- Have a history of prostate adenocarcinoma confirmed by biopsy and treated with surgery or radiation.
- Experienced a biochemical recurrence, indicated by rising PSA levels after treatment.
- No evidence of cancer spread on imaging tests.
- PSA doubling time of less than 10 months.
- Provide a tissue sample for genetic testing.
- ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Age 18 or older.
- Adequate organ and marrow function based on specific blood tests.
- Recovery from any previous treatment-related side effects.
- Able to understand and sign informed consent and follow study procedures.
- Male patients must agree to use contraception if their partners are of reproductive potential.
Exclusion Criteria
- Currently using or planning to start hormone therapy during the trial.
- Recent major surgery or radiation therapy within 14 days of starting the study.
- Active autoimmune disease requiring systemic treatment.
- Known immune deficiencies or chronic viral infections like HIV, hepatitis B, or hepatitis C.
- Use of systemic corticosteroids above a certain dose.
- Recent use of certain medications that affect PSA levels.
- Previous treatment with immune checkpoint inhibitors.
- Serious medical or psychiatric conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| St. Elizabeth's Medical Center | 02135 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| DFCI South Shore | 02190 | South Weymouth | Massachusetts |
| DFCI Londonderry | 03053 | Londonderry | New Hampshire |
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