BridgeMD
New treatment option 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 as a potential treatment for prostate cancer (adenocarcinoma).
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 is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
- 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. Participants may be enrolled on the study if, in the...
- Docetaxel criteria:
- Prior treatment with taxane chemotherapy
- Grade 2 or worse peripheral neuropathy
- Severe hypersensitivity to drugs formulated with polysorbate 80
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. Each participant must sign a consent form prior to enrollment in the trial to document their...
- 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...
- Docetaxel criteria:
- Prior treatment with taxane chemotherapy
- Grade 2 or worse peripheral neuropathy
- Severe hypersensitivity to drugs formulated with polysorbate 80
- Clinically significant cardiac disease including:
- 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. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- 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's taking place
- 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
+ 274 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 - 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?
Study sites include 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 288 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.