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New treatment option for Prostate Cancer
Official title Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)
ClinicalTrials.gov ID: NCT06772441
What this study is testing
What is Androgen deprivation therapy (ADT)?
Androgen deprivation therapy (ADT) is an investigational medicine, given as an once-daily injectable medicine, 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 aim of this prospective, single-arm phase II study is the individualization of both radiotherapy (RT) and androgen deprivation therapy (ADT) duration for patients with high-risk localized prostate cancer (PCa) according to the National Comprehensive Cancer Network (NCCN) based on multimodal artificial intelligence (MMAI) classification. All patients will receive (i) a dose escalation to the prostate via HDR brachytherapy (boost), (ii) twelve months of ADT and (iii) extremely hypofractionated RT to the prostate (5 fractions).
- 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
- Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should...
- Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI)
- High-risk according to NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA \> 20 ng/ml)
- Signed written informed consent for this study
- Age \>18 years
You likely can't join if
- Prior radiotherapy to the prostate or pelvis
- Prior radical prostatectomy
- 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
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)
- Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI)
- High-risk according to NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA \> 20 ng/ml)
- 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
- Prostate biopsy core with the highest ISUP grade available
- Prior radiotherapy to the prostate or pelvis
- Prior radical prostatectomy
- 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
- PSA \>50 ng/ml prior to starting of systemic therapy
- Expected patient survival \<5 years
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
- 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)
- Contraindication to Goserelin
- 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 treatment clinical trial within the last 30 days before the start of this trial
- Simultaneous participation in other treatment 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;
- Known or persistent abuse of medication, drugs or alcohol
- Patients expected to have severe set up problems (e.g. mental condition)
The study team makes the final eligibility decision.
Where it's taking place
- Limassol, Cyprus
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Limassol, Cyprus. 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.