Trial · NCT06866938
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival rate | At 24 weeks after the start of study treatment | Proportion (in %) of patients alive without disease progression at 24 weeks. Progression is defined by imaging (bone scan and CT-scan) according to RECIST 1.1 and/or PCWG3 criteria. |
| Secondary | Imaging-based radiographic progression (rPFS) | Through study completion, a maximum of 57 months | Imaging-based radiographic progression defined as the time from the first cycle of re-treatment to the date of radiographic disease progression or death from any cause. |
| Secondary | Overall survival | Through study completion, a maximum of 57 months | Overall Survival (Os) defined as the time from the first cycle of re-treatment to the date of death from any cause |
| Secondary | Objective response rate | Through study completion, a maximum of 57 months | Objective response rate (ORR) (Complete Response (CR) + Partial Response (PR)) measured by RECIST v1.1 response. |
| Secondary | Duration of response | Through study completion, a maximum of 57 months | Duration of response (DOR) will be measured in patients who achieved a CR or PR between the date of first response and the date of RECIST progression or death. |
| Secondary | Disease Control Rate | Through study completion, a maximum of 57 months | Disease control rate as measured by RECIST v1.1 response. Rates will be measured in soft tissue, lymph nodes and visceral lesions. |
| Secondary | Progression free survival | Through study completion, a maximum of 57 months | Progression free survival will be defined as the date of first cycle of \[177Lu\]Lu-PSMA-617 re-treatment to the date of first evidence of radiographic progression, clinical progression, PSA progression, or death from any cause, whichever occurs first. |
| Secondary | Biological response | Through study completion, a maximum of 57 months | Proportion of participants with a PSA response defined as a patient who has achieved a ≥ 50% PSA decrease from baseline that is confirmed with a second PSA measurement at ≥ 4 weeks. |
| Secondary | Time to PSA progression | Through study completion, a maximum of 57 months | Time to PSA progression will be defined as the date from first cycle of \[177Lu\]Lu-PSMA-617 re-treatment to a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir and confirmed by a second consecutive value obtained 3 or more weeks later. Where no decline from baseline is documented, PSA progression is defined as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks of treatment. |
| Secondary | Safety : Adverse Events | Through study completion, a maximum of 57 months | Safety of re-treatment will be assessed by percentage of patients with all grade and Serious AEs; percentage of patients with SAEs during the active follow up period; percentage of patients with an interruption of \[177Lu\]Lu-PSMA-617 re-treatment; Percentage of patients who discontinue \[177Lu\]Lu-PSMA-617 re-treatment secondary to an AEs or death; Number and grade of AE related to the investigational medicinal product or to the procedures added by the research |
| Secondary | Pain assessment | Up to 6 weeks from the last [177Lu]Lu-PSMA-617 administration | Pain will be assessed with the BPI-SF (Brief Pain Inventory - Short Form) questionnaire. BPI-SF is a multidimensional scale evaluating the intensity and the interference of pain in life activities: four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics. Pain severity: The BPI assesses pain at its "worst," "least," "average," and "now" (current pain); each of the forth items are used singly to represent pain severity. Pain interference: The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. This mean can be used if more than 50%, or four of seven, of the total items have been completed on a given administration. The highest is the score, the worst are the pain and pain interference |
| Secondary | Quality of life assessment | Up to 6 weeks from the last [177Lu]Lu-PSMA-617 administration | Aspects of HRQoL will be reported using Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. FACT-P score range 0-156; the higher the score, the better the QoL Subscales: Physical well-being (0-28) Social/Family well-being (0-28) Emotional well-being (0-24) Functional well-being (0-28) Prostate cancer subscale (0-48) |
| Secondary | Symptomatic Skeletal Event (SSE) assessment | Through study completion, a maximum of 57 months | Time to first symptomatic skeletal event (SSE) and SSE-free survival defined as date of first injection of \[177Lu\]Lu-PSMA-617 re-treatment to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, or requirement for radiation therapy to relieve bone pain, whichever occurs first. |
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.
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GET https://conductscience.org/api/trials/v1/NCT06866938/registered