Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (NCT04423211)
Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Anchorage Associates in Radiation Medicine โ Anchorage, Alaska
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (341 Sites)
Showing the first 25 of 341 sites.
- Anchorage Associates in Radiation Medicine โ Anchorage, Alaska
- Alaska Breast Care and Surgery LLC โ Anchorage, Alaska
- Alaska Oncology and Hematology LLC โ Anchorage, Alaska
- Alaska Women's Cancer Care โ Anchorage, Alaska
- Anchorage Oncology Centre โ Anchorage, Alaska
- Katmai Oncology Group โ Anchorage, Alaska
- Providence Alaska Medical Center โ Anchorage, Alaska
- Fairbanks Memorial Hospital โ Fairbanks, Alaska
- Cancer Center at Saint Joseph's โ Phoenix, Arizona
- Mercy Hospital Fort Smith โ Fort Smith, Arkansas
- Mission Hope Medical Oncology - Arroyo Grande โ Arroyo Grande, California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center โ Burbank, California
- Mercy Cancer Center - Carmichael โ Carmichael, California
- Mercy San Juan Medical Center โ Carmichael, California
- City of Hope Corona โ Corona, California
- City of Hope Comprehensive Cancer Center โ Duarte, California
- Mercy Cancer Center - Elk Grove โ Elk Grove, California
- UC San Diego Health System - Encinitas โ Encinitas, California
- UC San Diego Moores Cancer Center โ La Jolla, California
- City of Hope Antelope Valley โ Lancaster, California
- Los Angeles General Medical Center โ Los Angeles, California
- USC / Norris Comprehensive Cancer Center โ Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center โ Los Angeles, California
- Mercy Cancer Center โ Merced, California
- VA Palo Alto Health Care System โ Palo Alto, California
๐ Contact the Study Coordinator
Phone: (907) 212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Biochemically Recurrent Prostate Carcinoma
- Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer โ Atlanta, Georgia
- An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer โ Seattle, Washington
- RElugolix VErsus LeUprolide Cardiac Trial โ Atlanta, Georgia
- An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial โ Chicago, Illinois
- Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring โ Houston, Texas
Explore by condition: All Biochemically Recurrent Prostate Carcinoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.