Clinical trial for Prostate Cancer (Adenocarcinoma)
Official title Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
ClinicalTrials.gov ID: NCT06592924
What this study is testing
What is Abiraterone?
Abiraterone is an investigational medicine being studied to see if it helps lower the chance of prostate cancer growing or spreading. is designed to block the body from making certain hormones that can help prostate cancer cells grow.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding the drug docetaxel to standard hormone treatments lowers the chance of prostate cancer growing or spreading.
- Who it's for
- The study is looking for men with metastatic prostate cancer that is still sensitive to hormone treatment but has not responded well to initial therapy.
- What's involved
- Participants will receive standard hormone treatments along with docetaxel, or just the standard treatments, and will undergo regular tests to monitor their health.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically/cytologically confirmed adenocarcinoma of the prostate or participants with a PSA \>100 ng/ml (100 ug/L) and radiographic evidence of...
- Metastatic disease by conventional imaging (bone scan or CT and/or MRI or PSMA-PET scan at the time of ADT initiation.
- PSA of ≥ 2.0 ng/ml (2.0 ug/L) prior to commencement of ADT (this refers to patients who have histologically/cytologically confirmed adenocarcinoma of...
- Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator...
- Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are...
You likely can't join if
- Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value...
- Evidence of confirmed radiographic progression or clinical progression since start of ADT.
- Prior treatment with taxane chemotherapy
- Grade 2 or worse peripheral neuropathy
- Severe hypersensitivity to drugs formulated with polysorbate 80
- History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.
See the full eligibility criteria
- Histologically/cytologically confirmed adenocarcinoma of the prostate or participants with a PSA \>100 ng/ml (100 ug/L) and radiographic evidence of metastatic disease at diagnosis.
- Metastatic disease by conventional imaging (bone scan or CT and/or MRI or PSMA-PET scan at the time of ADT initiation.
- PSA of ≥ 2.0 ng/ml (2.0 ug/L) prior to commencement of ADT (this refers to patients who have histologically/cytologically confirmed adenocarcinoma of the prostate)
- Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).
- Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are clinically stable, not rapidly worsening, and not considered by the...
- Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months (+/- 3 weeks) at time of enrollment.
- Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months (+/- 2 weeks) at time of enrollment
- Patients may have had radiotherapy to prostatic bed and/or metastatic sites prior to enrollment. Potential trial participants should have recovered from radiotherapy-related toxicities prior to enrollment.
- Serum testosterone \<1.7 nmol/L or 50 ng/dL.
- PSA ≥ 0.2 ng/ml (0.2 ug/L) within 28 days of enrollment.
- Candidate for docetaxel chemotherapy
- ECOG Performance Status (PS) 0 to 2.
- Adequate organ and marrow function measured within 28 days prior to enrollment.
- Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
- Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events...
- In accordance with CCTG policy, protocol treatment is to begin within 10 working days of participant enrollment.
- If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception
- HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Participant access to all protocol therapies must be confirmed prior to enrollment
- Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value of 2.0 ng/ml (ug/L) above nadir, and a subsequent increase in PSA of...
- Evidence of confirmed radiographic progression or clinical progression since start of ADT. Participants may be enrolled on the study if, in the opinion of the investigator, any new bone lesions on bone scan and CT...
- Prior treatment with taxane chemotherapy
- Grade 2 or worse peripheral neuropathy
- Severe hypersensitivity to drugs formulated with polysorbate 80
- History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.
- History of documented congestive heart failure (New York Heart Association functions classification III-IV).
- Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.
- Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.
- Live attenuated vaccination administered within 30 days prior to enrollment/randomization.
- For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured.
- High-grade neuroendocrine prostate cancer or small cell features (except if a participant has no histological diagnosis but a PSA \>100 ng/ml (\>100 ug/L) at diagnosis and radiographic evidence of metastatic disease)
The study team makes the final eligibility decision.
Where it is enrolling
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Phoenix, Arizona, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Beverly Hills, California, United States
- Burbank, California, United States
- Carmichael, California, United States
- Duarte, California, United States
- Elk Grove, California, United States
- Emeryville, California, United States
- Fontana, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Merced, California, United States
+ 266 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Phoenix, Arizona, United States; Anaheim, California, United States; Arroyo Grande, California, United States; Baldwin Park, California, United States and 280 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.