RecruitingPhase 3

Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding docetaxel, a chemotherapy drug, to usual hormone treatment can lower the chance of prostate cancer growing or spreading. It is for people whose prostate cancer has spread and still responds to hormone treatment, but whose PSA blood test level has not fallen enough.

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. The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer confirmed by a tissue or cell test, or a PSA above 100 ng/ml with scans showing cancer spread at diagnosis. Scans must show spread when hormone treatment starts.
  • If cancer was confirmed by a tissue or cell test, PSA must have been at least 2.0 ng/ml before starting ADT, a treatment that lowers testosterone.
  • Have taken ADT for about 6–12 months and an ARPI, another hormone-blocking drug, for at least about 4 months.
  • Have testosterone below 50 ng/dL and PSA of at least 0.2 ng/ml. The PSA test must be within 28 days before joining.
  • Be able to receive docetaxel and care for yourself, even if you cannot work. Have good enough organ and bone marrow function on tests within 28 days before joining.
  • Have recovered from past treatment side effects, with some exceptions for mild or lasting effects. Stable ADT effects, such as hot flashes or tiredness, may be allowed if the study doctor considers them safe.
  • Sign a consent form, have access to all study drugs, and be available for treatment and follow-up. Study treatment must start within 10 working days after joining.
  • Agree to use accepted birth control if you and your partner could have a child. People with HIV may join if treatment is working and the virus was undetectable within 6 months.

Who can't join

  • Have confirmed cancer growth or spread since starting ADT, based on PSA tests, scans, or symptoms. Scan changes caused by treatment rather than cancer growth may be allowed.
  • Have had taxane chemotherapy before, have moderate or worse nerve damage, or have a severe allergy to drugs made with polysorbate 80.
  • Have serious heart disease, including recent unstable chest pain, heart attack, or swelling around the heart with symptoms, or severe heart failure.
  • Have an uncontrolled illness or another condition that would make treatment too risky. Another cancer may be allowed if it would not affect study safety or results.
  • Are taking other cancer drugs besides ADT and ARPI.
  • Received a live, weakened vaccine within 30 days before joining or being assigned a study treatment.
  • Have a history of hepatitis B with detectable virus, or hepatitis C that has not been cured, unless current hepatitis C treatment has made the virus undetectable.
  • Have high-grade neuroendocrine or small cell prostate cancer, which are special cancer types. An exception applies if there is no tissue diagnosis, PSA was above 100 ng/ml at diagnosis, and scans showed cancer spread.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Investigator to pose a safety risk or impair the patient's ability to comply with study procedures. Such toxicities do not need to resolve to Grade ≤1 prior to study entry. * 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 willingness to participate. * 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, and follow-up. * 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 Exclusion Criteria: * 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 25% further separated by 3 or more weeks. * 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 represent flare or treatment effect. * 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 efficacy assessment of the investigational regimen are eligible for this trial. * 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 viral load. * 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)

Study sites (374)

AK

AZ

CA

CO

CT

DC

DE

FL

GA

HI

IA

ID

IL

KY

LA

MD

MI

MN

MO

MS

  • University of Mississippi Medical Center · Jackson, MS 39216Site Public Contact · Study contact · 601-815-6700John C. Henegan · Principal investigatorMore trials in Jackson

MT

NC

ND

NE

NH

NY

OH

OK

OR

PA

RI

SC

TN

  • Vanderbilt University/Ingram Cancer Center · Nashville, TN 37232Site Public Contact · Study contact · 800-811-8480Kerry R. Schaffer · Principal investigatorMore trials in Nashville

TX

UT

VA

VT

WA

WI

WY