Study on Adding Docetaxel to Hormone Therapy for Metastatic Castration Sensitive Prostate Cancer with Suboptimal PSA Response
Sponsor: Canadian Cancer Trials Group
ClinicalTrials ID:NCT06592924
This clinical trial is exploring whether adding the drug Docetaxel to the usual hormone therapy can better control prostate cancer that has spread and has not responded well to initial treatment.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out if adding the chemotherapy drug Docetaxel to the standard hormone therapy can help control prostate cancer that has spread and has not responded well to initial treatment. The usual treatment involves hormone therapy with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitors (ARPI). This study will compare the effectiveness of adding Docetaxel to this standard treatment.
Description
This international study involves patients with metastatic castration sensitive prostate cancer (mCSPC) who have not had a good response to hormone therapy after 6-12 months. The trial will compare two groups: one receiving the standard hormone therapy (ADT and ARPI) and the other receiving the same therapy plus the chemotherapy drug Docetaxel. The goal is to see if the addition of Docetaxel can improve outcomes for these patients.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate cancer that has spread.
- PSA level of 5.0 ng/ml or higher before starting hormone therapy.
- Have been on hormone therapy (ADT) for 6 to 12 months.
- Have been on ARPI treatment for at least 4 months.
- Must have recovered from any significant side effects of previous treatments.
- Low testosterone levels (below 1.7 nmol/L or 50 ng/dL).
- PSA level of 0.2 ng/ml or higher within 14 days of joining the study.
- Eligible for Docetaxel chemotherapy.
- Good overall health with an ECOG performance status of 0 to 2.
- Adequate organ and bone marrow function.
- Must provide informed consent and be willing to participate in the study.
- Must be available for treatment and follow-up.
- Must start treatment within 5 days of joining the study.
- Must agree to use contraception if of childbearing potential.
- HIV-positive participants must have an undetectable viral load on treatment.
- Must have access to all study treatments before joining.
Exclusion Criteria
- Two consecutive increases in PSA levels after starting hormone therapy.
- Evidence of cancer progression on scans or symptoms since starting hormone therapy.
- Previous treatment with taxane chemotherapy.
- Moderate to severe nerve damage.
- Severe allergic reactions to certain drug ingredients.
- Significant heart disease or history of heart problems.
- Uncontrolled illness or other conditions that make the study unsafe.
- Other cancers that could interfere with the study.
- Receiving other cancer treatments besides ADT and ARPI.
- Recent live vaccinations.
- Hepatitis B must be under control if previously infected.
- Hepatitis C must be treated and cured, or under control if currently being treated.
- High-grade neuroendocrine prostate cancer or small cell features.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Mission Hope Medical Oncology - Arroyo Grande | 93420 | Arroyo Grande | California |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | 91505 | Burbank | California |
| Mercy Cancer Center - Carmichael | 95608 | Carmichael | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.