Verteporfin for Primary localized prostate cancer | Prostate cancer

Inclusion criteria

• {"criterion_text":"- Subjects ≥ 18 years.\n- Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.\n- Adequate renal function as defined by creatinine ≤ 1.5 mg /dl\n- Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.\n- Only persons who use an effective method of contraception (condom is recommended) or whose sexual partner is de facto unable to conceive a child for other reasons are included.\n- Signed Informed Consent.\n- Histologically confirmed organ-confined prostate cancer diagnosed within the last 9 months. Including subjects on active surveillance with evidence of disease progression and a prostate biopsy not older than 9 months. a.\tThis prostate biopsy should be targeted and systematic (transperineal or transrectal are both acceptable) and include both systematic sampling with a minimum of 8 cores (4 right, 4 left) as well as MRI fusion targeted cores. The minimum number of targeted cores is two (2) but more may be included at the discretion of the surgeon.\n- Gleason Score 7 (3+4 or 4+3).\n- PSA ≤ 15 ng/mL.\n- Lesion volume on mpMRI < 1.5 cm3.\n- Adequate stage imaging such as pelvic CT/MRI/PET scan within the last 6 months confirming localized cancer. • Bone scan is optional if PSA < 10 ng/mL.\n- Treatment target volume <50 cm3 defined by TRUS or MRI.\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n- Expected survival ≥ 36 months."}

Exclusion criteria

• {"criterion_text":"- Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease.\n- Use of Alpha-reductase inhibitors (ARIs) within 90 days of enrolment.\n- Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).\n- Mental incapacity or psychiatric illness that would interfere with the subject’s ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator.\n- Contraindication for photosensitizer including: a.\tPorphyria or other diseases exacerbated by light. b. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients. c. Known allergies to porphyrins.\n- On-going therapy with a photosensitizing agent.\n- Enrolment in another therapeutic clinical study within 3 month prior to enrolment and throughout the study.\n- Contraindication for MRI/Gadolinium contrast such as: implants, hip prosthesis, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2), or previous contrast reactions.\n- Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium\n- Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI\n- Contralateral PIRADS 4/5 lesion (even if negative targeted biopsy)\n- High volume GG1 disease in the contralateral prostate, outside of the ablation zone. High volume is defined as >1 core of GG1 with a linear amount of carcinoma >6mm.\n- Prior radical surgery for carcinoma of the prostate, prior pelvic radiation, prior TURP, prior cryosurgery of the prostate.\n- Prior treatment with any form of brachytherapy.\n- Previous androgen deprivation therapy (ADT) or chemotherapy for prostate cancer.\n- Prior or current bleeding diathesis.\n- Tumors known to be eroding into a major blood vessel in or adjacent to the illumination site."}

Primary endpoints

• {"endpoint_text":"- Safety: Assessment of toxicity according to CTCAE v5.0 related to therapy per protocol. In addition, any PDT-mediated severe damage to the periprostatic tissues will be evaluated by MRI images obtained 5-9 days post-PDT. The threshold for success is anticipated to be no Grade 3 toxicity to the rectum or bladder assessed on MRI or any drug-related Serious Adverse Events.","definition_or_measurement_approach":"Toxicity assessed according to CTCAE v5.0 related to therapy per protocol; evaluation of PDT-mediated severe periprostatic tissue damage by MRI obtained 5-9 days post-PDT. Success threshold: no Grade 3 toxicity to rectum or bladder on MRI and no drug-related Serious Adverse Events."}

Secondary endpoints

• {"endpoint_text":"- Device performance: Light dose coverage >90% of the target volume evaluated by dose-volume histograms in >80% of subjects.","definition_or_measurement_approach":"Light dose coverage measured by dose-volume histograms; endpoint success defined as >90% coverage of target volume in >80% of subjects."}
• {"endpoint_text":"- Adequacy of effectiveness: Extent of quantifiable treatment effect in the prostate evaluated by MRI one-week post-PDT by calculating the percentage of necrosis evaluated by MRI. Descriptive statistics will be presented for each subject.","definition_or_measurement_approach":"MRI one week post-PDT used to calculate percentage of necrosis in prostate; descriptive statistics presented per subject."}
• {"endpoint_text":"- Efficacy: Percentage of subjects with negative in-field biopsies (histopathologically tumour free) at 6 months. A proportion of subjects with negative biopsies of 0.75 at 6 months in phase 2 is expected and is considered clinically meaningful. The rate of negative in-field biopsy at 6 and 18 months as defined by the Delphi consensus criterion (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant).","definition_or_measurement_approach":"Assessment by in-field biopsy histopathology at 6 and 18 months; negative defined per Delphi consensus criterion (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core)."}

Methods

• Recruitment arrangements document(s) submitted (documents titled 'K1_Recruitment arrangements' and 'K2_Recruitment material').
• Recruitment materials include a website (document 'K2_Recruitment material_website') and a video transcript (document 'K2_Recruitment materia_video transcript').

Germany

Earliest CTIS Part Ii Submission Date

28-04-2025

Latest Decision Or Authorization Date

05-12-2025

Processing Time Days

221

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

SpectraCure AB (publ)

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Viedoc Technologies AB

Responsibilities

eCRF

Name

Simbec-Orion (NL) B.V.

Responsibilities

Statistics, parts of study management

Name

Propharma Group Mis Limited

Responsibilities

PV

Third parties

• {"country":"Sweden","full_name":"Viedoc Technologies AB","duties_or_roles":"eCRF","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Sweden","full_name":"G Ahlgren läkarkonsult AB","duties_or_roles":"","organisation_type":"Health care"}
• {"country":"Netherlands","full_name":"Simbec-Orion (NL) B.V.","duties_or_roles":"Statistics, parts of study management","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Propharma Group Mis Limited","duties_or_roles":"PV","organisation_type":"Pharmaceutical company"}