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Antiandrogen

Apalutamide + Targeted Radiation for Prostate Cancer

Phase 3

Recruiting

Led By Neha Vapiwala

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy

Creatine < 1.5 x instituional ULN (or measured creatinine clearance > 30 mL/min)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether adding apalutamide to standard treatment, with or without targeted radiation therapy, helps patients with prostate cancer that has come back after treatment.

Who is the study for?

Men with prostate cancer that has returned after surgery, evidenced by rising PSA levels. They must be suitable for standard radiation and hormone therapy, have no spread of cancer outside the pelvis as confirmed by imaging, and meet specific health criteria like adequate blood counts and liver function.

What is being tested?

The trial is testing if adding apalutamide (a drug blocking male hormones used by tumor cells) to standard care improves outcomes in patients whose prostate cancer has returned post-surgery. It also examines whether targeted radiation based on PET scan results offers additional benefits.

What are the potential side effects?

Apalutamide can cause fatigue, high blood pressure, skin rash, falls or fractures due to bone weakness. Radiation may lead to urinary issues or bowel discomfort. The combination could increase the risk of these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have inflammatory bowel disease or any condition that affects how my body absorbs food.

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My kidney function tests are within normal limits.

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I can lie still for 20-30 minutes for a scan or radiation treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I am a man and at least 18 years old.

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I had surgery to remove my prostate due to cancer.

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I have not had seizures or conditions that could lead to seizures in the last year.

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I am eligible for radiation and hormone therapy after prostate surgery.

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My cancer has returned after prostate surgery.

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I have never had radiation therapy to my pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS prolongation in patients with PET-evidence of extrapelvic metastases

PFS prolongation in patients without PET-evidence of extrapelvic metastases

Progression-free survival (PFS)

+1 more

Secondary study objectives

Change in FACT-P and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

Comparison - Functional Assessment of Cancer Therapy (FACT)- prostate (P)

Concordance of detection rate with the follow-up conventional imaging modalities (CIM)

+9 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

87%

Fatigue

53%

Nausea

33%

Cough

27%

Pain

27%

Fall

27%

Dyspnea

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

27%

Anemia

20%

Chills

20%

Dizziness

20%

Edema limbs

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

13%

Dysesthesia

13%

Dysgeusia

13%

Myalgia

13%

Edema

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Skin infection

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Headaches

Oral lesions

Weakness (facial)

Neutrophil count decreased

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Creatinine increased

Headache

Death NOS

Gait disturbance

Nasal congestion

Fever

Tremor

Urinary urgency

Hypoxic respiratory failure

Amnesia

Photophobia

Pleural effusion

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Muscle weakness

Erythema multitforme

Lung infection

Hypertension

Allergy (seasonal)

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm D (EBRT, STAD, apalutamide, RT)Experimental Treatment18 Interventions

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (EBRT, STAD, apalutamide)Experimental Treatment13 Interventions

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.

Group III: Arm B (EBRT, STAD, apalutamide)Experimental Treatment13 Interventions

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 months in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (EBRT, short-term androgen deprivation therapy [STAD])Active Control12 Interventions

STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2. STEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Triptorelin

2017

Completed Phase 4

~1560

Relugolix

2016

Completed Phase 3

~5410