Trial Outcomes & Findings for Modeling Clinical Failure in Prostate Cancer Patients Based on a Two-stage Statistical Model (NCT NCT03979079)

Results Overview

Clinical failure is defined as any of the following events following initiation of radiotherapy: distant metastases, nodal recurrence, or any palpable or biopsy-detected local recurrence three years after radiation; any local recurrence within three years of RT if the most previous PSA was\>2 ng/ml; and death from prostate cancer.

Recruitment status

COMPLETED

Target enrollment

2384 participants

Primary outcome timeframe

within 10 years following initiation of radiotherapy

Results posted on

2021-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Eligible Prostate Cancer Patients Undergoing EBRT Treatment
Overall Study STARTED	2384
Overall Study COMPLETED	2384
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eligible Patients n=2384 Participants Eligible Prostate Cancer Patients Undergoing EBRT Treatment
Age, Continuous	72 years STANDARD_DEVIATION 4.7 • n=2384 Participants
Sex: Female, Male Female	0 Participants n=2384 Participants
Sex: Female, Male Male	2384 Participants n=2384 Participants

PRIMARY outcome

Timeframe: within 10 years following initiation of radiotherapy

Clinical failure is defined as any of the following events following initiation of radiotherapy: distant metastases, nodal recurrence, or any palpable or biopsy-detected local recurrence three years after radiation; any local recurrence within three years of RT if the most previous PSA was\>2 ng/ml; and death from prostate cancer.

Outcome measures

Outcome measures
Measure	Patients n=2384 Participants All patients
Number of Participants With Clinical Failure After Initiation of Radiotherapy	315 Participants

SECONDARY outcome

Timeframe: within 10 years following initiation of radiotherapy

Outcome measures

Outcome measures
Measure	Patients n=2384 Participants All patients
Number of Participants With Initiation of Salvage Therapy After Radiotherapy	267 Participants

POST_HOC outcome

Timeframe: within 10 years following initiation of radiotherapy

Outcome measures

Outcome measures
Measure	Patients n=2384 Participants All patients
Prognostic Value of Hormone Therapy on the Risk of Clinical Failure.	0.21 hazard ratio Interval 0.14 to 0.3

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Carine Bellera

Institut Bergonié

Phone: 33 0 5 56 33 04 95

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place