NCT04423211PHASE3RECRUITING

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Sponsor: ECOG-ACRIN Cancer Research Group + National Cancer Institute (NCI)

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Interventions

3-Dimensional Conformal Radiation Therapy, Apalutamide, Computed Tomography, Degarelix

Enrollment

804 participants

Primary completion

Dec 2032

Study completion

Dec 2032

First posted

Jun 2020

Last updated

May 2026

Primary Endpoints (CT.gov)

Progression-free survival (PFS)

Time frame: From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years

PFS prolongation in patients without PET-evidence of extrapelvic metastases

Time frame: Up to 10 years

PFS prolongation in patients with PET-evidence of extrapelvic metastases

Time frame: Up to 10 years

Quality of life (QOL)

Time frame: Up to 24 months

Secondary Endpoints

Overall survival (OS)

Event-free survival

Time to prostate-specific antigen (PSA) progression

Eligibility Criteria

Inclusion Criteria: * STEP 0: REGISTRATION ELIGIBILITY CRITERIA * Patient must be male and \>= 18 years of age. * Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma * Patient must have biochemical recurrence (BCR) after RP, defined as follows: * If time to BCR, defined as time to first detectable PSA ( \> lower limit of normal for assay used) after RP, is \< 12 months, a minimum PSA level of \>= 0.2 ng/mL and a confirmatory reading of \>= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible) * If time to BCR, defined as time to first detectable PSA (\> lower limit of normal for assay used) after RP, is \>= 12 months, a minimum absolute PSA of 0.5 ng/mL is required * If the patient has a detectable PSA (\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC…

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov