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Compares treatment options for Prostate Adenocarcinoma
Official title Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
ClinicalTrials.gov ID: NCT05946213
What this study is testing
- What it's testing
- This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision.
- Phase 3: a large, late-stage study
- Time commitment: about 2 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
- High-risk disease defined as having at least one or more of the following:
- cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is...
- The patient's prostate specific antigen (PSA) value \> 20 ng/mL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha...
- Gleason Score of 8-10
See the full eligibility criteria
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
- High-risk disease defined as having at least one or more of the following:
- cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is not allowed
- The patient's prostate specific antigen (PSA) value \> 20 ng/mL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The...
- Gleason Score of 8-10
- Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
- Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan
- No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen...
- Age \>= 18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- No prior radical prostatectomy
- No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound [HIFU], laser ablation, cryotherapy, irreversible electroporation [IRE]...
- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone [LHRH] agonist and oral anti-androgen) is =\< 185 days prior to...
- No contraindication to prostate MRI (required for planning of radiotherapy in both arms)
- Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tuscaloosa, Alabama, United States
- Little Rock, Arkansas, United States
- Antioch, California, United States
- Beverly Hills, California, United States
- Dublin, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Oakland, California, United States
- Orange, California, United States
- Rancho Cordova, California, United States
- Redwood City, California, United States
- Richmond, California, United States
- Rohnert Park, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
+ 294 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tuscaloosa, Alabama, United States; Little Rock, Arkansas, United States; Antioch, California, United States; Beverly Hills, California, United States; Dublin, California, United States and 308 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.