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Protocol # 21-031

Status

Recruiting

Description

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

Condition

  • Metastatic Malignant Neoplasm in the Bone
  • Prostate Adenocarcinoma
  • Stage III Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8

Interventions

  • Apalutamide
  • Bicalutamide
  • Buserelin
  • Degarelix
  • Flutamide
  • Goserelin
  • Histrelin
  • Leuprolide
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Radiation Therapy
  • Triptorelin

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Metastasis-free survival (MFS)

Secondary Outcome:

  • MFS
  • Overall survival
  • Prostate cancer specific mortality (PCSM)
  • Prostate specific antigen (PSA) failure-free survival with non-castrate testosterone and no additional therapies
  • Time to testosterone recovery
  • Time to PSA failure or salvage therapy
  • Testosterone levels at the time of PSA failure and metastases
  • Incidence of adverse events

Enrollment

2478

Study Start Date

December 15, 2020

Eligibility

  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

NRG Oncology

Source

NRG Oncology

Official title

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

Clinicaltrials.gov Identifier

NCT04513717

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.