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New treatment option for Prostate Cancer
Official title MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)
ClinicalTrials.gov ID: NCT06150417
What this study is testing
What is Androgen deprivation therapy (ADT)?
Androgen deprivation therapy (ADT) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out if giving radiation therapy (RT) to areas of metastatic prostate cancer at the time a participant is diagnosed will help control disease better than the usual treatment. This treatment is called metastasis-directed radiotherapy (MDRT).
- Phase 2: a mid-size study of how well it works
- 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
- Participant must be ≥ 18 years of age.
- Participant must have an ECOG performance status ≤ 1.
- Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or...
- There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.
- Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease.
You likely can't join if
- Participants with the presence of any of the following:
- Castration resistant prostate cancer (CRPC).
- Evidence of visceral or intracranial metastases.
- Participant receiving any other investigational agents for cancer.
- Participant is participating in a concurrent treatment protocol for cancer.
- Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
See the full eligibility criteria
- Participant must be ≥ 18 years of age.
- Participant must have an ECOG performance status ≤ 1.
- Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET/CT. Biopsy of sites of metastasis is...
- There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.
- Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease.
- Participants may have started LHRH agonist or antagonist therapy, and/or androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the participant is enrolled on this study.
- In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and/or extra-pelvic lymph node (LN) stations.
- Extra-pelvic LN stations are superior to the regional/pelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.
- Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and/or heterogeneous morphology
- In participants who undergo PSMA PET/CT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and/or extra-pelvic LN stations. The MI-RADS reporting...
- In participants extra-pelvic nodal (M1a) disease only by PSMA PET/CT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be...
- 1\. PSA ≥ 40
- 2\. Evidence of cN1 disease (pelvic LN)
- 3\. Decipher score ≥ 0.89
- Adequate organ and marrow function to receive treatment per treating physician
- Medically fit for treatment and agreeable to follow-up.
- Ability to understand and the willingness to sign a written informed consent.
- Participants with the presence of any of the following:
- Castration resistant prostate cancer (CRPC).
- Evidence of visceral or intracranial metastases.
- Participant receiving any other investigational agents for cancer.
- Participant is participating in a concurrent treatment protocol for cancer.
- Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
- Prior definitive treatment to the primary prostate cancer or pelvis.
- Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes...
- History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence
- Active Crohn's disease or ulcerative colitis despite medical management.
- Refusal to sign informed consent.
- Any condition that in the opinion of the investigator would preclude participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
- Madison, 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 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 Cleveland, Ohio, United States; Madison, 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.