Docetaxel for Metastatic Castration Sensitive Prostate Cancer

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

Recruiting Phase 3 Interventional Study
Prostate Cancer (Adenocarcinoma)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
830 (estimated)
Sponsor
Canadian Cancer Trials Group · Research network
Who this trial is looking for

This trial is looking for men with prostate cancer that has spread and is responding poorly to current treatment. Participants will receive additional medication to see if it helps lower cancer growth and spread.

Are You a Good Fit for This Trial?
Must be taking Androgen Deprivation TherapyAndrogen-Receptor Pathway Inhibitor

You may be able to join if

  • I have prostate cancer that has spread.
  • I have a PSA level of at least 2.0 ng/ml.
  • I have been on hormone treatment for at least 6 months.
  • I am receiving androgen receptor pathway inhibitor treatment.
  • I am a candidate for docetaxel chemotherapy.
  • I have my doctor’s approval to participate.
  • I can provide consent to join the trial.
  • I can attend follow-up appointments.

You may not be able to join if

  • I have seen my PSA level increase significantly recently.
  • I have had severe heart problems recently.
  • I have received other cancer treatment besides hormone therapy.
  • I have uncontrolled serious health issues.
  • I have had a severe allergic reaction to certain drugs.
  • I have a history of severe nerve damage.
  • I have had a live vaccine within 30 days of joining.
  • I have high-grade neuroendocrine prostate cancer.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 Ther…
Trial Locations
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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 th…
Contacts

Mariam Jafri

613-533-6430

mjafri@ctg.queensu.ca

CONTACT

Wendy Parulekar

613-533-6430

wparulekar@ctg.queensu.ca

CONTACT