Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04457245

Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer — PSMA-dRT  

Stage III Prostate Cancer AJCC v8 Clinical Trial

Official title:
Phase 3 Randomized Trial Of PSMA PET Prior to Definitive Radiation Therapy for Unfavorable Intermediate-Risk or High-Risk Prostate Cancer [PSMA dRT]

Clinical Trial Summary

This randomized phase III trial studies the success rate of definitive radiation therapy (dRT) for prostate cancer (PCa) with or without planning based on PSMA PET. PSMA- PET-based dRT, may improve radiation therapy planning and patient selection for dRT, and potentially improve its outcome compared to dRT without PSMA PET (standard dRT).

Clinical Trial Description

PRIMARY OBJECTIVE: I. To compare the outcome of patients with unfavorable intermediate (IR) and high-risk (HR) prostate cancer (PCa) after standard dRT versus prostate-specific membrane antigen (PSMA) positron emission tomography (PET)-based dRT. OUTLINE: Patients are randomized to 1 of 2 arms. In both arms, no other primary treatment should be given before RT. Arm I: Patients do not undergo PSMA PET for dRT planning. Patients undergo standard of care dRT at the discretion of the treating radiation oncologist. Arm II: Patients undergo PSMA PET for dRT planning. Patients then undergo dRT at the discretion of the treating radiation oncologist, who receives the PSMA PET result and images. After completion of dRT, clinical follow-up of patients with their treating radiation oncologist will be obtained for 5 years. The investigators will rely on the medical records obtained from the treating physicians as the primary source of outcome data. ;

Study Design

Related Conditions & MeSH terms

  • Prostatic Neoplasms
  • Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
  • Stage II Prostate Cancer AJCC v8
  • Stage IIA Prostate Cancer AJCC v8
  • Stage IIB Prostate Cancer AJCC v8
  • Stage IIC Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8
Clinical Trial Details
NCT number NCT04457245
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact
Status Terminated
Phase Phase 3
Start date August 14, 2020
Completion date January 10, 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Recruiting NCT04981834 - Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer N/A
Completed NCT04976257 - Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion Early Phase 1
Recruiting NCT06173362 - Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer Phase 2
Suspended NCT03899987 - Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Not yet recruiting NCT06129851 - Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer Phase 2
Not yet recruiting NCT05487846 - Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation N/A
Recruiting NCT05946213 - Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer Phase 3
Active, not recruiting NCT03570827 - Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy Phase 2
Recruiting NCT03987386 - Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer Phase 3
Not yet recruiting NCT06325046 - Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer N/A
Recruiting NCT04134260 - Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer Phase 3
Completed NCT03177460 - Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer Phase 1
Active, not recruiting NCT05320406 - RElugolix VErsus LeUprolide Cardiac Trial Phase 4
Completed NCT04067960 - Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer Early Phase 1
Suspended NCT04037254 - Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer Phase 2
Recruiting NCT05869682 - Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy Phase 2
Recruiting NCT06389786 - Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer N/A
Recruiting NCT05877144 - Low-Intensity Shockwave Therapy to Treat Erectile Dysfunction and Preserve Erectile Function After Prostate Cancer Surgery N/A