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New treatment option for Prostate Cancer (Adenocarcinoma)
Official title The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)
ClinicalTrials.gov ID: NCT07038304
What this study is testing
- What it's testing
- In patients with metastatic prostate cancer (PCa) who receive androgen deprivation therapy (ADT), the sensitivity to castration will eventually disappear due to the selection of castration-refractory clones. This will lead to the stage of metastatic castration-refractory prostate can-cer (mCRPC), which is incurable and results in a median overall survival of 2-3 years.
- Phase 2: a mid-size study of how well it works
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
- Adenocarcinoma of the prostate.
- mCRPC setting, with testosterone level \< 50 ng/dl or 1.7 nmol/l.
- Oligoprogressive disease diagnosed on PSMAscan; defined as the progression of pre-existing metastatic disease, and/or the appearance of new...
- Patients currently treated with ADT, whether combined with another systemic treatment such as ARTA, chemotherapy.
- For patients treated with chemotherapy, the course should be completed or stopped before start MORT - In case of treatment with ARTA, a minimal of 3...
You likely can't join if
- Serum testosterone level \> 50 ng/ml or \> 1.7 nmol/l.
- Presence of more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion).
- Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or...
- Local recurrence in the prostate after previous radiotherapy
- Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible.
- Disorder precluding understanding of trial Information or informed consent or signing informed consent.
See the full eligibility criteria
- Adenocarcinoma of the prostate.
- mCRPC setting, with testosterone level \< 50 ng/dl or 1.7 nmol/l.
- Oligoprogressive disease diagnosed on PSMAscan; defined as the progression of pre-existing metastatic disease, and/or the appearance of new metastases and/or the appearance of a local relapse with a maximum of 3 lesions...
- Patients currently treated with ADT, whether combined with another systemic treatment such as ARTA, chemotherapy.
- For patients treated with chemotherapy, the course should be completed or stopped before start MORT - In case of treatment with ARTA, a minimal of 3 months response (PSA or clinical response).
- WHO performance status 0-2.
- Age \> = 18 years old.
- Patiënt should be presented at the multidisciplinary tumor board of the local hospital in which the therapy will be given.
- Before patiënt registration, written informed consent must be given according to ICH/GCO and national/local regulations.
- Serum testosterone level \> 50 ng/ml or \> 1.7 nmol/l.
- Presence of more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion).
- Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma.
- Local recurrence in the prostate after previous radiotherapy
- Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible.
- Disorder precluding understanding of trial Information or informed consent or signing informed consent.
- Evidence of PSMA-negative disease.
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
- Nijmegen, Netherlands
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 Groningen, Netherlands; Nijmegen, Netherlands. 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.