AD ASTRA (Androgen Deprivation with Apalutamide and STereotactic RAdiotherapy)

Conditions

Localized or a locally advanced high-risk prostate cancer

Brief summary

5-year biochemical control rate defined as a percentage of surviving patients without biochemical progression after 5 years since the treatment start (assessed by Kaplan-Meier estimate).

Detailed description

Major secondary endpoint: Metastasis free survival based on PSMA PET/CT (assessed by Kaplan-Meier estimate)., 5-year biochemical control rate with PSA <0.2 ng/mL., 5-year prostate cancer specific survival., 5-year overall survival (OS). OS is defined as the time from enrollment to date of death from any cause., Incidence of acute and late side effects and complications associated with radiotherapy and systemic treatment evaluated by Common Terminology Criteria of Adverse Event (CTCAE) and Patient Reported Outcomes (PRO) including QoL questionnaires., Effect of the planned interventions on QoL (I-PSS, EPIC-26, FACT-P, EQ-5D-5L, PRO-CTCAE™ (short version)).

Related papers

No related papers found yet.

Interventions

DRUGAPALUTAMIDE

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
5-year biochemical control rate defined as a percentage of surviving patients without biochemical progression after 5 years since the treatment start (assessed by Kaplan-Meier estimate).	—

Secondary

Measure	Time frame
Major secondary endpoint: Metastasis free survival based on PSMA PET/CT (assessed by Kaplan-Meier estimate)., 5-year biochemical control rate with PSA <0.2 ng/mL., 5-year prostate cancer specific survival., 5-year overall survival (OS). OS is defined as the time from enrollment to date of death from any cause., Incidence of acute and late side effects and complications associated with radiotherapy and systemic treatment evaluated by Common Terminology Criteria of Adverse Event (CTCAE) and Patient Reported Outcomes (PRO) including QoL questionnaires., Effect of the planned interventions on QoL (I-PSS, EPIC-26, FACT-P, EQ-5D-5L, PRO-CTCAE™ (short version)).	—

Measure

Time frame

Major secondary endpoint: Metastasis free survival based on PSMA PET/CT (assessed by Kaplan-Meier estimate)., 5-year biochemical control rate with PSA <0.2 ng/mL., 5-year prostate cancer specific survival., 5-year overall survival (OS). OS is defined as the time from enrollment to date of death from any cause., Incidence of acute and late side effects and complications associated with radiotherapy and systemic treatment evaluated by Common Terminology Criteria of Adverse Event (CTCAE) and Patient Reported Outcomes (PRO) including QoL questionnaires., Effect of the planned interventions on QoL (I-PSS, EPIC-26, FACT-P, EQ-5D-5L, PRO-CTCAE™ (short version)).

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Countries

Slovakia

Outcome results

None listed