What is apalutamide studying for prostate cancer recurrence?

Apalutamide is being studied to see if adding it to standard radiation and hormone therapy improves outcomes in men with prostate cancer that has come back after surgery. The trial compares this enhanced therapy with standard care alone to understand if it can better control cancer progression. The study is led by the ECOG-ACRIN Cancer Research Group and uses advanced imaging to guide treatment.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 years or older with prostate cancer that has returned after surgery, shown by rising PSA levels, may be eligible. Participants must have had a prostatectomy and be candidates for radiation and hormone therapy. Patients with certain medical conditions or prior pelvic radiation may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drugs, radiation, and all trial visits, is provided at no cost. Personal travel expenses vary and may not be covered by the study. Participants should plan accordingly for any transportation or lodging costs.

Actively Recruiting

Phase 3

Age: 18Years +

MALE

ID04423211

Phase III Study of Local or Systemic Therapy Intensification Directed by PET in Prostate Cancer Patients With Post-Prostatectomy Biochemical Recurrence (INDICATE)

Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-15

804

Participants Needed

342

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, specifically those with biochemical recurrence indicated by rising prostate specific antigen (PSA) levels. This phase III trial examines whether adding enhanced therapy, which includes apalutamide combined with abiraterone and prednisone, to standard care (prostate radiation therapy and short-term androgen deprivation) improves outcomes compared to standard care alone. The study also explores if adding targeted radiation to metastatic sites identified by PET imaging benefits patients whose cancer has spread beyond the pelvis. Participants undergo a baseline PET scan using CT or MR imaging to detect cancer spread. Based on these results, they are randomized into one of four treatment groups: standard radiation plus androgen deprivation; standard radiation, androgen deprivation, and apalutamide; similar treatments for those with metastases; and a group receiving additional targeted radiation to metastatic sites. Treatments last approximately six months, with radiation delivered through various advanced techniques, and hormonal therapies given via injections or orally. Some patients may have repeat PET scans during the study to monitor disease progression. During the trial, participants will have regular follow-up visits every three months for two years, then less frequently up to ten years. Researchers will assess progression-free survival, overall survival, PSA levels, quality of life, cognitive function, and adverse events. Quality of life and fatigue questionnaires are administered at several time points. Safety and treatment responses will be closely monitored using imaging and lab tests throughout the study duration.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Male patients 18 years or older
Histopathologically confirmed prostate adenocarcinoma treated with radical prostatectomy
Biochemical recurrence after prostatectomy defined by specific PSA criteria
No evidence of extrapelvic metastases by conventional imaging within 26 weeks prior to registration
Eligible baseline PET scan using FDA-approved radiotracer within 16 weeks prior to registration
Candidate for standard post-prostatectomy radiation therapy with androgen deprivation therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
No prior androgen deprivation therapy for biochemical recurrence before baseline PET
Ability to understand and sign informed consent (or have legal representative if impaired)
Ability to lie flat and tolerate PET scan and radiation treatment
Meet local MRI safety guidelines if undergoing PET/MR
Adequate blood counts and liver and kidney function within 8 weeks prior to registration
No history of seizures or predisposition to seizures within 1 year
No inflammatory bowel disease or gastrointestinal disorder increasing radiotherapy risk
Agree not to father children during the study
English or Spanish speaking for quality of life assessments

You will not qualify if you...

Female patients
Prior pelvic radiation therapy
Started androgen deprivation therapy for biochemical recurrence before baseline PET
Enrolled in another therapeutic clinical trial
History of seizures or conditions causing predisposition to seizures within 1 year prior to registration
History of inflammatory bowel disease or gastrointestinal disorders affecting absorption
Inadequate blood counts or liver/kidney function
Unable to lie flat or tolerate PET scan or radiation treatment
Not able to understand or sign informed consent without authorized representative
Not English or Spanish speaking for quality of life components
Evidence of extrapelvic metastatic disease by conventional imaging not meeting study criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 16 weeks prior to treatment

Participants undergo standard of care PET/CT or PET/MR scan to determine eligibility and to identify the presence of metastases.

1 baseline imaging visit (in-person)

Treatment

Duration - 6 months or until disease progression or unacceptable toxicity

Participants receive external beam radiation therapy (EBRT) for 6 months along with androgen deprivation therapy. Some participants also receive apalutamide, and those with identified extrapelvic metastases may receive additional targeted radiation therapy such as stereotactic body radiation therapy (SBRT) or other advanced radiation techniques over 3 to 10 fractions.

Radiation therapy visits and drug administration visits over 6 months

Follow-up

Duration - Up to 10 years

After completing treatment, participants are followed up regularly to monitor health, disease status, and quality of life.

Every 3 months for 2 years, every 6 months for years 3-5, then annually for years 6-10

Trial Site Locations

Total: 342 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Alaska Breast Care and Surgery LLC