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New treatment option for Prostate Cancer (Adenocarcinoma)
Official title Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer
ClinicalTrials.gov ID: NCT07219303
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time.
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
- people must have histologically confirmed intermediate- and favorable high risk (AJCC 8th ed stage IIA-IIC) adenocarcinoma of the prostate.
- Age \> 18 years.
- ECOG performance status ≤ 2
- Prostate volume (segmented) ≤ 100 cc determined by MRI and/or US within 24 mo of treatment for patients not on ADT and within 6 mo for patients on...
- people must have had a pre-treatment diagnostic multiparametric MRI prostate (mpMRI) showing a PI-RADS3, 4 or 5 lesion or a 68Ga- or 18F-PSMA...
You likely can't join if
- people must not be experiencing toxicity CTCAE grade ≥ 3 GU or GI toxicity at baseline.
- people must not be receiving any other investigational agents.
- people must not have had prior pelvic radiation therapy.
- people must not have node-positive disease.
- people must not have extraprostatic extension determined by MRI prostate within 24 mo of treatment. For patients receiving ADT, the prostate MRI must...
- people must not have had prior ablative therapies for prostate cancer including cryosurgery, HIFU and nanoknife.
See the full eligibility criteria
- people must have histologically confirmed intermediate- and favorable high risk (AJCC 8th ed stage IIA-IIC) adenocarcinoma of the prostate.
- Age \> 18 years.
- ECOG performance status ≤ 2
- Prostate volume (segmented) ≤ 100 cc determined by MRI and/or US within 24 mo of treatment for patients not on ADT and within 6 mo for patients on prior ADT. A simulation MRI is acceptable.
- people must have had a pre-treatment diagnostic multiparametric MRI prostate (mpMRI) showing a PI-RADS3, 4 or 5 lesion or a 68Ga- or 18F-PSMA (TLX591-CDx or piflufolastat F18) PET/CT within 12 mo of study registration.
- Baseline International Prostate Symptom Score (IPSS) is ≤ 15. Baseline alpha blocker use is allowed.
- people must have full capacity to understand and be willing to sign the informed consent document.
- people must not be experiencing toxicity CTCAE grade ≥ 3 GU or GI toxicity at baseline.
- people must not be receiving any other investigational agents.
- people must not have had prior pelvic radiation therapy.
- people must not have node-positive disease.
- people must not have extraprostatic extension determined by MRI prostate within 24 mo of treatment. For patients receiving ADT, the prostate MRI must have been obtained prior to the start of ADT.
- people must not have had prior ablative therapies for prostate cancer including cryosurgery, HIFU and nanoknife.
- people with prior TURP or laser enucleation are eligible. However, patients that have undergone prior simple prostatectomy are excluded.
- people that are receiving other antineoplastic agents including methotrexate are ineligible. people that have received prior ADT are eligible if they have received \ 6 mo prior to registration and serum total...
- people must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).
- people with active inflammatory bowel disease or active collagen vascular disorder.
- people that cannot undergo prostate fiducial placement.
- people that cannot undergo rectal spacer placement are excluded. Please, note that a rectal spacer incorporating iodine or similar CT contrast is preferred. However, patients that are able to only have a non-contrast...
- people that cannot undergo prostate MRI.
- people with bilateral prosthetic hips will be excluded. people with unilateral prosthetic hips will be eligible only if the initial treatment plan meets all target and normal tissue constraints without protocol...
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Philadelphia, Pennsylvania, 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.