Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes (NCT06439225)
๐ฉบ Plain-English Summary (8th-Grade Level)
The usual approach for most patients who are not in a study is treatment with docetaxel. 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 approach? This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (24 items) and avoid the listed exclusions (13 items).
Location: Arthur J.E. Child Comprehensive Cancer Centre โ Calgary, Alberta
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Received prior platinum chemotherapy (i.e. carboplatin, cisplatin, oxaliplatin, satraplatin) or prior taxane chemotherapy (docetaxel, paclitaxel, cabazitaxel) at any time for the treatment of prostate cancer with the exception of docetaxel for mCSPCor adjuvant therapy after curative intent treatment for localized prostate cancer, as long as it was no more than 6 cycles and at least 12 months have elapsed from their last treatment to the date of enrollment. If the participant received prior platinum or taxane chemotherapy for other cancers, then please contact the CCTG office to discuss this further with the trial team.
- Active anticancer systemic therapy or investigational agents within 14 days of randomization.
- Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure (NYHA Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
- Participants with myelodysplastic syndrome/acute myeloid leukemia.
- Malignancy within the previous 2-years with a \> 30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer, and in-situ or superficial bladder cancer.
- Participants with known symptomatic brain metastasis. However, participants with asymptomatic, treated brain metastases that have been stable for at least 12 weeks are eligible for study entry.
- Participants with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable and asymptomatic.
- Presence of a condition or situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participation in the study.
- Live attenuated vaccination administered within 30 days prior to randomization.
- For patients with known immunodeficiency virus (HIV) infection, the HIV viral load must be undetectable on effective anti-retroviral therapy within 6 months of enrollment.
- For participants with evidence 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (14 Sites)
- Arthur J.E. Child Comprehensive Cancer Centre โ Calgary, Alberta
- Cross Cancer Institute โ Edmonton, Alberta
- BCCA - Vancouver โ Vancouver, British Columbia
- William Osler Health System โ Brampton, Ontario
- Waterloo Regional Health Network (WRHN) โ Kitchener, Ontario
- London Health Sciences Centre Research Inc. โ London, Ontario
- Ottawa Hospital Research Institute โ Ottawa, Ontario
- Odette Cancer Centre โ Toronto, Ontario
- University Health Network โ Toronto, Ontario
- CHUM-Centre Hospitalier de l'Universite de Montreal โ Montreal, Quebec
- The Jewish General Hospital โ Montreal, Quebec
- CHU de Quebec-Hopital l'Enfant-Jesus (HEJ) โ Quรฉbec, Quebec
- Allan Blair Cancer Centre โ Regina, Saskatchewan
- Saskatoon Cancer Centre โ Saskatoon, Saskatchewan
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.