Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

NCT03987386 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2018-0703NCI-2018-03367
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 3

Brief Summary

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Conditions

Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity

  Will be denoted as Tc and Te for conventional and hypo-fractionated arm respectively.

  At 2 years

Secondary Outcomes (12)

• Local control

  Up to 5 years

• Loco-regional control

  Up to 5 years

• Distant metastases

  Up to 5 years

• Biochemical progression-free survival

  Up to 5 years

• Prostate-cancer specific survival (PCSS)

  Up to 5 years

Study Arms (2)

Arm I (conventional radiation therapy)

ACTIVE COMPARATOR

Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy

Arm II (hypofractionated radiation therapy)

EXPERIMENTAL

Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.

Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

Arm II (hypofractionated radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (conventional radiation therapy); Arm II (hypofractionated radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Arm I (conventional radiation therapy); Arm II (hypofractionated radiation therapy)

Radiation Therapy RADIATION

Undergo conventional radiation therapy

Also known as: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Arm I (conventional radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men age 18 or older
• Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted
• Patient has pathologic T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology
• For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of \>= 0.1. PSA \>= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT)
• Patient diagnosed with Gleason score of 6-10
• Eastern Cooperative Oncology Group (ECOG) performance 0-2
• Patients may receive 6 months and up to 24 months of androgen deprivation therapy. Patients may have received androgen deprivation therapy up to 12 months prior to postoperative radiotherapy
• If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer

You may not qualify if:

• Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region
• Neoadjuvant chemotherapy before or after prostatectomy
• History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome
• History of severe active co-morbidity or uncontrolled diabetes
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
• End-stage renal disease (i.e., on dialysis or dialysis has been recommended)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson League City

League City, Texas, 77573, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation Dose Hypofractionation; Radiation; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Therapeutics; Physical Phenomena

Study Officials

• Quynh-Nhu Nguyen

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: June 17, 2019
• Study Start: May 30, 2019
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (3)