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

ConditionsBiochemically Recurrent Prostate CarcinomaMetastatic Prostate CarcinomaProstate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorECOG-ACRIN Cancer Research Group

About this trial

This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \[PSA\] after surgical removal of the prostate cancer).

A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested.

Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3-Dimensional Conformal Radiation Therapy

    Radiation

    Undergo 3D CRT

  • Apalutamide

    Drug

    Given PO

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Degarelix

    Drug

    Given SC

  • External Beam Radiation Therapy

    Radiation

    Undergo EBRT

  • Fluciclovine F18

    Other intervention

    Given IV

  • Goserelin Acetate

    Drug

    Given SC

  • Intensity-Modulated Proton Therapy

    Procedure/Surgery

    Undergo IMPT

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo IMRT

  • Leuprolide Acetate

    Drug

    Given IM

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo PET/MR

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT or PET/MR

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Relugolix

    Drug

    Given PO

  • Stereotactic Body Radiation Therapy

    Radiation

    Undergo SBRT

  • Triptorelin

    Drug

    Given IM

  • Volume Modulated Arc Therapy

    Radiation

    Undergo VMAT

Treatment groups

804 Participants
are divided into 4 treatment groups
Group A: Arm A (EBRT, short-term androgen deprivation therapy [STAD])Active comparator 12 interventions
Group B: Arm B (EBRT, STAD, apalutamide)Experimental treatment 13 interventions
Group C: Arm C (EBRT, STAD, apalutamide)Experimental treatment 13 interventions
Group D: Arm D (EBRT, STAD, apalutamide, RT)Experimental treatment 18 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function

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
2

PFS prolongation in patients without PET-evidence of extrapelvic metastases

Will evaluate whether the addition of enhanced systemic therapy to standard of care salvage therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel with patients with PET-evidence of extrapelvic metastases.

Time frame
Up to 10 years
3

PFS prolongation in patients with PET-evidence of extrapelvic metastases

Will evaluate whether the addition of metastasis-directed radiation therapy to standard of care salvage therapy and enhanced systemic therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel without patients with PET-evidence of extrapelvic metastases.

Time frame
Up to 10 years
4

Quality of life (QOL)

Descriptive statistics will be used to characterize QOL over time in each arm.

Time frame
Up to 24 months

Secondary outcomes

1

Overall survival (OS)

Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare OS between the two arms in each cohort.

Time frame
From randomization to death or date last known alive, assessed up to 10 years
2

Event-free survival

Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare EFS between the two arms in each cohort.

Time frame
From randomization to radiographic progression by conventional imaging or PET, symptomatic disease, or initiation of new treatment for the disease or death, whichever occurs first, assessed up to 10 years
3

Time to prostate-specific antigen (PSA) progression

Patients without any progression will be censored at the date of last disease assessment that shows free of PSA progression. Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare time to PSA progression between the two arms in each cohort.

Time frame
From randomization to documented PSA progression or radiographic progression, whichever occurs first, assessed up to 10 years
4

Incidence of adverse events

Toxicity will be defined using the Common Terminology Criteria for Adverse Events.

Time frame
Up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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