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New treatment option for Localized Prostate Adenocarcinoma
Official title Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
ClinicalTrials.gov ID: NCT06325046
What this study is testing
- What it's testing
- This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose.
- Time commitment: about 60 months
- 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
- Gender assigned male at birth: age ≥ 18 years
- Histological confirmation of prostate adenocarcinoma
- National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to complete questionnaire(s) by themselves or with assistance
You likely can't join if
- NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
- Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
- Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate...
- Metastatic disease by conventional or molecular imaging
- Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
- Concurrent antineoplastic agents (chemotherapy)
See the full eligibility criteria
- Gender assigned male at birth: age ≥ 18 years
- Histological confirmation of prostate adenocarcinoma
- National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to complete questionnaire(s) by themselves or with assistance
- Signed informed consent
- Willing to complete requirements for follow-up (during active monitoring phase)
- NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
- Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
- Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.
- Metastatic disease by conventional or molecular imaging
- Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
- Concurrent antineoplastic agents (chemotherapy)
- Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years
- Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up
- Prostate gland volume \> 80 cc based on magnetic resonance imaging (MRI), and/or International Prostate Symptom Score (IPSS) composite score \> 17
- Body weight \> 200 kilogram
- Known allergy or sensitivity to polyethylene glycol (PEG) or iodine
The study team makes the final eligibility decision.
Where it's taking place
- Albert Lea, Minnesota, United States
- Mankato, Minnesota, United States
- Rochester, Minnesota, United States
- Eau Claire, Wisconsin, United States
- La Crosse, Wisconsin, United States
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 60 months 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 Albert Lea, Minnesota, United States; Mankato, Minnesota, United States; Rochester, Minnesota, United States; Eau Claire, Wisconsin, United States; La Crosse, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.