GOSERELIN for Prostate cancer

Inclusion criteria

• {"criterion_text":"- 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)\n- Prostate biopsy core with the highest ISUP grade available\n- High- or very hih-risk according to NCCNv4.2023 criteria\n- Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI))\n- Signed written informed consent for this study\n- Age >18 years\n- Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR\n- MMAI low-/intermediate-risk\n- ECOG Performance score 0 or 1\n- IPSS Score ≤15"}

Exclusion criteria

• {"criterion_text":"- Prior radiotherapy to the prostate or pelvis\n- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed\n- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial;\n- Prior radical prostatectomy\n- Known or persistent abuse of medication, drugs or alcohol\n- Patients expected to have severe set up problems (e.g. mental condition)\n- Prior focal therapy approaches to the prostate\n- Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT\n- Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT\n- Time gap between the beginning of any systemic therapy, ADT and conduction of PSMA-PET scans is >2 months\n- Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT\n- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts\n- PSA >50 ng/ml prior to starting of systemic therapy\n- Expected patient survival <5 years\n- Contraindication to Goserelin\n- Contraindication to undergo a MRI scan\n- 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)\n- Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization\n- Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia\n- 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\n- Any other contraindication to external beam radiotherapy (EBRT) to the pelvis\n- Participation in any other interventional clinical trial within the last 30 days before the start of this trial"}

Primary endpoints

• {"endpoint_text":"- Disease-free survival 5 years after treatment. Disease recurrence is defined as PSA failure according to Phoenix, new lesions on PSMA PET and/or MRI imaging or the beginning of any salvage therapy.","definition_or_measurement_approach":"Disease-free survival at 5 years post-treatment; disease recurrence defined as: PSA failure according to Phoenix, new lesions on PSMA PET and/or MRI imaging, or initiation of any salvage therapy. Outcome measured over a 5-year follow-up period."}

Secondary endpoints

• {"endpoint_text":"- Time to local or regional failure; after end of RT. Local or regional recurrences have to be confirmed by PSMA-PET or mpMR imaging. For the diagnosis of local failure, verification via biopsy is warranted.","definition_or_measurement_approach":"Time from end of RT to confirmed local or regional recurrence; confirmation by PSMA-PET or mpMRI and biopsy for local failure where indicated."}
• {"endpoint_text":"- Metastatic free survival (MFS) after end of RT, (all metastases have to be confirmed by PSMA-PET/CT or mpMR imaging)","definition_or_measurement_approach":"Time from end of RT to first occurrence of confirmed distant metastasis; confirmation required by PSMA-PET/CT or mpMRI."}
• {"endpoint_text":"- Overall (OS) and prostate cancer specific (PCSS) survival after end of RT","definition_or_measurement_approach":"Overall survival and prostate cancer-specific survival measured from end of RT; deaths classified by cause."}
• {"endpoint_text":"- Time to biochemical failure after end of RT (phoenix definition)","definition_or_measurement_approach":"Time from end of RT to biochemical failure defined by the Phoenix definition (nadir+2 ng/mL)."}
• {"endpoint_text":"- Patient reported quality of life (QOL: EPIC-CP, IPSS and IIEF-5)","definition_or_measurement_approach":"Patient-reported outcomes assessed using EPIC-CP, IPSS and IIEF-5 questionnaires at specified timepoints."}
• {"endpoint_text":"- Cumulative acute genitourinary (GU) and gastrointestinal (GI) toxicities during and up to 3 months after RT using the RTOG criteria","definition_or_measurement_approach":"Acute GU and GI toxicity graded with RTOG criteria during RT and up to 3 months post-RT; cumulative incidence recorded."}
• {"endpoint_text":"- Cumulative chronic GU and GI toxicities after RT using the RTOG and CTCAEv5.0 criteria","definition_or_measurement_approach":"Chronic GU and GI toxicities assessed post-RT and graded using RTOG and CTCAE v5.0 criteria; cumulative incidence recorded."}
• {"endpoint_text":"- Testosterone recovery","definition_or_measurement_approach":"Assessment of testosterone levels over time post-ADT to evaluate recovery to predefined thresholds."}

Cyprus

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

26-02-2025

Processing Time Days

306

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Linac-Pet Scan Opco Limited

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Cyprus