Trial comparing treatments 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
- The study is checking whether the shorter, high‑dose radiation schedule prevents the cancer from coming back as well as the standard longer schedule.
- Who it's for
- Men who have high‑risk prostate cancer (stage III or IVA).
- What's involved
- Participants will be assigned to receive either five precise radiation treatments over two weeks or the usual 20‑45 treatments over 4‑9 weeks, with imaging and routine check‑ups.
- Time commitment
- Treatment lasts up to 9 weeks, with scheduled clinic visits during and after therapy for follow‑up.
- 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
- 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
- Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
See the full eligibility criteria
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
- 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)
- 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 is enrolling
- 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
+ 306 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, but 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?
This study is enrolling now at 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 320 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.