BridgeMD
"APalutamide and stEReotactic body radiation therapy for low burden metastatic hormone senSItive prostate cancer, a rANdomized trial -PERSIAN".
EU CTIS ID: 2022-501894-37-00
What this study is testing
To compare the benefit, in terms of rate of complete biochemical response at 6 months from treatment start (PSA < 0.2 ng/ml), obtained adding stereotactic body radiotherapy on all sites of metastatic disease in patients affected by oligometastatic hormone sensitive prostate carcinoma, undergoing androgen deprivation therapy and Apalutamide. Study will compare patients undergoing standard systemic treatment alone, consisting of androgen deprivation therapy + Apalutamide (Arm A: Control) versus patients undergoing the same systemic treatment associated with stereotactic body radiotherapy on all sites of metastatic disease (Arm B: Treatment).
- Therapeutic exploratory (Phase II)
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
- Patients who have signed written informed consent
- Adult patients ≥ 18 years
- Oligometastatic hormone sensitive prostate cancer defined as presence of <= 5 non-visceral metastatic lesions
- All lesions must be amenable to SBRT in judgment of treating radiation oncologist
- Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered
- Androgen deprivation therapy (ADT) started <= 6 months before enrollment
You likely can't join if
- Presence of visceral disease
- De novo metastatic disease
- Any contraindication to the use of Apalutamide
- Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated
See the full eligibility criteria
- Patients who have signed written informed consent
- Adult patients ≥ 18 years
- Oligometastatic hormone sensitive prostate cancer defined as presence of <= 5 non-visceral metastatic lesions
- All lesions must be amenable to SBRT in judgment of treating radiation oncologist
- Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered
- Androgen deprivation therapy (ADT) started <= 6 months before enrollment
- Patients should be eligible to Apalutamide treatment
- Presence of visceral disease
- De novo metastatic disease
- Any contraindication to the use of Apalutamide
- Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated
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.