Prostate-only, dose-escalated radiotherapy plus concomitant androgen deprivation therapy in primary localized, NCCN high risk and MMAI classifier low or intermediate-risk prostate cancer – a prospective, single-arm, phase II study - HypoPro

inac-Pet Scan Opco Limited0 sites30 target enrollmentFebruary 13, 2024

ConditionsProstate cancer MedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864 Therapeutic area: Diseases [C] - Neoplasms [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate cancer
Sponsor: inac-Pet Scan Opco Limited
Enrollment: 30
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 13, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

inac-Pet Scan Opco Limited

Eligibility Criteria

Inclusion 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

Exclusion Criteria

•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