Whole-pelvis Hypofractionated Radiotherapy Combined With Dose-escalation to the Prostate and Androgen Deprivation Therapy in Primary Localized, NCCN and MMAI High-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence (MMAI). All patients will receive the current standard of care: (i) a dose escalation to the prostate via HDR brachytherapy, (ii) two years of ADT and (iii) whole-pelvis UHF-RT (5 fractions).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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- or very high-risk according to NCCNv1.2023 criteria
• Signed written informed consent for this study
• Age \>18 years
• Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR
• MMAI high-risk
• ECOG Performance score 0 or 1
• IPSS Score ≤15
Locations
Other Locations
Cyprus
German Oncology Center
RECRUITING
Limassol
Contact Information
Primary
Elena Pallari, PhD
elena.pallari@goc.com.cy
0035725028690
Backup
Kristis Vevis, PhD
kristis.vevis@goc.com.cy
0035725208159
Time Frame
Start Date:2024-09-16
Estimated Completion Date:2027-08-31
Participants
Target number of participants:30
Treatments
Experimental: Single experimental arm
RT prostate (HDR brachytherapy): 15 Gy (D90) in 1 fraction HDR RT prostate~EBRT elective pelvis (Ultra-hypofractionated RT - UHF): 25 Gy in 5 Gy per fraction~Technique: IMRT/IGRT/HDR brachytherapy~Duration: 6 fractions, 3 weeks~Androgen deprivation therapy (ADT) - Goserelin: all patients receive ADT; luteinising-hormone-releasing hormone agonists or antagonists for 24 months~Follow-up (FU) per patient: minimum FU time is 5 years (60 months), the study ends when the last enrolled patients reaches 60 months of FU time~Further FU: by the end of this clinical trial it will be decided whether further FU is necessary, amendment to this clinical trial protocol will be done in appropriate time