BridgeMD
Comparison of targeted radiotherapy with and without short-term hormonal treatment (6 months)
EU CTIS ID: 2024-511252-41-00
What this study is testing
The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
- Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA > O.lng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect).
- Maximum 4 lesions (bone + lymph nodes) in total, without evidence of viscerai metastases. a. Nodal relapse (NI) in the pelvis on PSMA-PET scan with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation. b. Nodal relapse (Ml) on PSMA-PET scan above the aortic bifurcation with a maximum of 3 positive lymph nodes. c. Bone relapse on PSMA-PET scan with a maximum of 3 lesions.
- Age > 18 years.
- PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.
- PSA < 10 ng/ml.
You likely can't join if
- Visceral metastases.
- PSA => 10 ng/ml.
- PSA-doubling time < 3 months.
- ADT or chemotherapy for recurrent PCa.
- Testosterone < 1.7 nmol/l.
- Painful metastases needed pain medication.
See the full eligibility criteria
- Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
- Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA > O.lng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect).
- Maximum 4 lesions (bone + lymph nodes) in total, without evidence of viscerai metastases. a. Nodal relapse (NI) in the pelvis on PSMA-PET scan with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation. b. Nodal relapse (Ml) on PSMA-PET scan above the aortic bifurcation with a maximum of 3 positive lymph nodes. c. Bone relapse on PSMA-PET scan with a maximum of 3 lesions.
- Age > 18 years.
- PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.
- PSA < 10 ng/ml.
- In case of chronic use of finasteride the PSA value should be < 5 ng/ml.
- WHO performance state 0-2.
- DSigned informed consent prior to registration/randomization.
- Visceral metastases.
- PSA => 10 ng/ml.
- PSA-doubling time < 3 months.
- ADT or chemotherapy for recurrent PCa.
- Testosterone < 1.7 nmol/l.
- Painful metastases needed pain medication.
- Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers.
- Inability to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.