Phase 3
Completed N=296
Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer
Prostate Adenocarcinoma · Stage I Prostate Adenocarcinoma AJCC v7 · Stage II Prostate Adenocarcinoma AJCC v7 · Stage III Prostate Adenocarcinoma AJCC v7
Source: ClinicalTrials.gov NCT03274687 ↗
Enrolled (actual)
296
Serious AEs
3.1%
Results posted
Jun 2022
Primary outcomePrimary: Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years — -4.12; -5.06 units on a scale — p=0.98
◆ Published Evidence
Established
39citations · ~20 / year
Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial.
Summary
This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. 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. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.
Linked Publications
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Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years |
-4.12; -5.06 | 0.98 |
| PRIMARY Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years |
-1.42; -4.21 | 0.96 |
| SECONDARY Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years |
-4.34; -7.90; 0.08; -1.71; -2.32; -5.41 | 0.70 |
| SECONDARY Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years |
-6.83; -14.96; -1.90; -2.70; -2.67; -3.11 | 0.0011 sig |
| SECONDARY Percentage of Participants With Biochemical Failure |
8.3; 11.8; 3.5; 8.0 | 0.29 |
| SECONDARY Percentage of Participants With Progression |
14.4; 14.7 | 0.96 |
| SECONDARY Percentage of Participants With Local-Regional Failure |
0.7; 0.8 | 0.35 |
| SECONDARY Percentage of Participants Receiving Salvage Therapy |
7.5; 5.8 | 0.41 |
| SECONDARY Percentage of Participants With Distant Metastasis |
0.7; 2.2 | 0.60 |
| SECONDARY Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality) |
0; 0 | — |
| SECONDARY Percent of Participants Alive (Overall Survival) |
98.6; 98.5 | 0.61 |
| SECONDARY Number of Participants With Grade 3+ Adverse Events |
25; 20; 3; 2; 6; 10 | 0.53 |
Eligibility Criteria
Inclusion Criteria
- PRIOR TO STEP 1 REGISTRATION
- Adenocarcinoma of the prostate treated primarily with radical prostatectomy
- Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted; there is no time limit for the date of radical prostatectomy
- One of the following pathologic T-classifications: pT2 or pT3
- Patients with positive surgical margins are eligible
- One of the following pathologic N-classifications: pN0, pNX
- If a lymph node dissection is performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator versus [vs.] extended lymph node dissection) should be noted whenever possible
- No clinical evidence of regional lymph node metastasis
- Computed tomography (CT) (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection of the pelvis within 120 days prior to step 1 registration
- Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are = = 45 days after prostatectomy and within 30 days prior to step 1, = 0.2 ng/mL AND Gleason >= 7 (Considered for NRG-GU002, principal investigator [PI]: Hurwitz)
- pT2 with a negative surgical margin and PSA 6 months (180 days) duration;
- Note: The use of finasteride or dutasteride (+/- tamsulosin) for longer periods prior to prostatectomy is acceptable
- Androgen deprivation therapy started after prostatectomy and prior to step 1 registration for > 6 weeks (42 days)
- Neoadjuvant chemotherapy before or after prostatectomy
- Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years and not in the pelvis; (for example, carcinoma in situ of the oral cavity is permissible if disease free for a minimum of 3 years; however, patients with prior history of bladder cancer are not allowed no matter the disease free duration); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy is not allowed
- Previous chemotherapy for any other disease site if given within 3 years prior to step 1
- Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy treatment volumes
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration
- Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
- Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count = 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
- End-stage renal disease (ie, on dialysis or dialysis has been recommended)
- Prior allergic reaction to the study drugs involved in this protocol
- History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason
Data sourced from ClinicalTrials.gov (NCT03274687) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.