Trial · NCT06765954
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Pathologic Response (CPR) after pre-radiation immunotherapy. | CPR: Assessed within approximately 6 weeks of study start. | Complete Pathologic Response (CPR) after pre-radiation immunotherapy: Assesses the complete absence of cancer in tissue samples taken after the pre-radiation immunotherapy phase. This signifies a complete eradication of the cancer at that stage of the treatment process. |
| Primary | PSA30 response at end-of-treatment (EOT) after post-radiation immunotherapy | Assessed at EOT, which occurs roughly 30 to 39 weeks after the study begins. | Measures a ≥30% reduction in Prostate-Specific Antigen (PSA) levels from baseline to the end of treatment. PSA is a common biomarker used to monitor prostate cancer treatment success. A decrease in PSA suggests successful treatment in reducing the cancer burden. |
| Secondary | Clinical Pathologic Response (after pre-radiation immunotherapy) | Within approximately 6 weeks of the study start. | Clinical Pathologic Response (CPR) is an assessment of the extent of tumor reduction after treatment, combining clinical (imaging) and pathological (tissue examination) findings. In this study, CPR is evaluated both after pre-radiation and post-radiation immunotherapy. The specific criteria for determining CPR will vary depending on whether it's assessed by imaging or pathology. |
| Secondary | Time to Recurrence Interval (TTRI) | Variable, ranging from the end of radiation therapy (around 2-9 weeks after pre-radiation immunotherapy, depending on individual schedules) to up to 5 years (260 weeks). | This measures the time elapsed between the completion of radiation therapy and the recurrence of the cancer. Longer TTRI indicates more durable treatment results. |
| Secondary | Safety (AEs and SAEs) | Continuous monitoring throughout the entire study duration (approximately 303 weeks). | Safety will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) throughout the study, graded using the CTCAE v5.0 scale. |
| Other | Quality of Life (QoL) | Approximately 5 years | Assessed using validated questionnaires |
| Other | Sexual Function | Approximately 13 Months | Assessed using the Sexual Health Inventory for Men (SHIM) questionnaire. |
| Other | Changes in Immune Subsets and Antigen-Specific Immune Responses | Approximately 13 Months | This evaluates the effects of the treatment on the immune system, looking for changes in various immune cells and their responses to specific cancer antigens. |
| Other | PSA Levels | Approximately 13 months | Prostate-specific antigen (PSA) is a protein produced by the prostate gland. PSA levels in the blood are commonly used as a marker to monitor prostate cancer. |
| Other | Tumor Microenvironment (TME) | Pre-radiation TME: Approximately 6 weeks after study start. Post-radiation TME: Approximately 30-39 weeks after study start. | Evaluated through analysis of tissue samples using whole slide images, spatial transcriptome, immunohistochemistry, and bulk RNA sequencing. |
| Other | Circulating Tumor DNA (ctDNA) | Approximately 5 years | Measured to assess the presence of cancer DNA in the blood. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06765954/registered