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Artificial Intelligence driven personalisation of radiotherapy and concomitant androgen deprivation therapy for prostate cancer patients
EU CTIS ID: 2024-510707-11-00
What this study is testing
The individualization of radiotherapy (RT) based on prostate-specific membrane antigen positron emission tomography / computed tomography (PSMA PET/CT) imaging and a multimodal artificial intelligence (MMAI) system in terms de-intensification of hormonal therapy in parallel to ultra-hypofractionated RT and dose escalation to the prostate has no decreased disease-free survival. A reduction both in overall treatment duration (6 fractions) and shortening of proposed ADT will further increase the patients’ convenience.
- 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
- Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)
- Prostate biopsy core with the highest ISUP grade available
- High- or very hih-risk according to NCCNv4.2023 criteria
- Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI))
- Signed written informed consent for this study
- Age >18 years
You likely can't join if
- Prior radiotherapy to the prostate or pelvis
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
- Prior radical prostatectomy
- Known or persistent abuse of medication, drugs or alcohol
- Patients expected to have severe set up problems (e.g. mental condition)
See the full eligibility criteria
- Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)
- Prostate biopsy core with the highest ISUP grade available
- High- or very hih-risk according to NCCNv4.2023 criteria
- Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI))
- Signed written informed consent for this study
- Age >18 years
- Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR
- MMAI low-/intermediate-risk
- ECOG Performance score 0 or 1
- IPSS Score ≤15
- Prior radiotherapy to the prostate or pelvis
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;
- Prior radical prostatectomy
- Known or persistent abuse of medication, drugs or alcohol
- Patients expected to have severe set up problems (e.g. mental condition)
- Prior focal therapy approaches to the prostate
- Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT
- Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT
- Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is >2 months
- Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
- PSA >50 ng/ml prior to starting of systemic therapy
- Expected patient survival <5 years
- Contraindication to Goserelin
- Contraindication to undergo a MRI scan
- Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anaesthesia)
- Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
- Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
- Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
- Any other contraindication to external beam radiotherapy (EBRT) to the pelvis
- Participation in any other interventional clinical trial within the last 30 days before the start of this trial
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.