Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer

NCT04225299 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: CLIN1901 PCM306
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-center, prospective, randomized controlled clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer. The study will include criteria for evaluation, biopsy, eligibility, informed consent, subsequent management and decision making conducted based on data provided locally at each center that follow a set of standardized criteria.

Conditions

Localized Prostate Cancer

Keywords

Prostatic Disease; Genital Neoplasm,male; Urogenital neoplasm; Genital disease,male; Male urogenital disease; Neoplasms; Neoplasms by site; Prostatic neoplasm; Carcinoma

Outcome Measures

Primary Outcomes (1)

• Rate of objective progression

  To evaluate the difference in the rate of objective progression of cancer between men treated with TOOKAD -VTP and men managed with Active Surveillance for localized prostate cancer.

  over 30 months

Secondary Outcomes (24)

• Rate of conversion to radical local or systemic therapy

  over 30 and 72 months

• Rate of conversion to radical local or systemic therapy following objective progression

  over 30 and 72 months

• Rate of biopsy progression in the index lobe

  at 30 and 72 months

• Rate of clinical local or distant progression

  Screening,Month 12, Month 24,Month 42 and Month 60

• Adverse events and Serious Adverse events

  Screening-Month 72

Study Arms (2)

TOOKAD®

EXPERIMENTAL

TOOKAD® , lyophilized formulation, given at a dose of 4mg/Kg.

Drug: TOOKAD®

Active Surveillance

NO INTERVENTION

Active surveillance is one of the management strategy in men who have intermediate risk localised prostate cancer

Interventions

TOOKAD® DRUG

TOOKAD® -VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance

Also known as: WST11

TOOKAD®

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men 18 years or older.
• Men who have chosen Active Surveillance as the treatment for their prostate cancer.
• Patients who have had a multiparametric MRI of the prostate performed and have undergone transrectal systematic biopsy plus biopsy of any lesions (or "areas") considered suspicious per the MRI (PIRADS version 2 score of 4 or 5) within 6 months before signing consent.
• Unilateral Grade Group 2 (Gleason grade 3+4=7) prostate cancer with a total length of Gleason pattern 4 no more than 2mm when measured in all systematic biopsy cores plus up to 1 core from each targeted biopsy lesion (if more than 1 core is taken from a given lesion the core with the longest length of pattern 4 will be included). Note: the presence and length of Grade Group 1 (Gleason score 3+3=6) cancer in the biopsy will not be considered when determining eligibility.
• Prostate cancer clinical stage up to cT2a, N0/Nx, M0/Mx.
• Prostate volume ≥20 mL and ≤80 mL
• Serum PSA ≤10 ng/mL.
• Patients with cT2a and PSA between 10 and 20 ng/mL will have appropriate imaging and work up to sufficiently exclude clinical evidence of bone metastases (e.g., bone scan, whole body MRI, PET scan, or equivalent). Patients with sites considered "suspicious" may be evaluated with confirmatory biopsy to determine eligibility. Patients with sites considered "definite" or "consistent with" bone metastases will be excluded.
• Men who are sexually active with women of childbearing potential must use contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days after the VTP procedure. The individual methods of contraception may be determined in consultation with the investigator.
• Signed Informed Consent Form.

You may not qualify if:

• Grade Group 3, 4 or 5 (≥ Gleason Score 4+3=7) cancer
• In patients with Grade Group 2 cancers, a total length of Gleason pattern 4 more than 2mm when measured in all systematic biopsy cores plus up to 1 core from each targeted biopsy lesion (if more than 1 core is taken from a given lesion, include the mm of pattern 4 in the 1 core with the longest length of pattern 4)
• Bilateral GG 2 cancer
• MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE, or MRI lesion with \>10mm capsular contact, in an area with biopsy proven cancer).
• Seminal vesicle invasion on DRE or MRI ("probable" or "consistent with")
• Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
• Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy) or chemotherapy;
• Life expectancy less than 10 years;
• Participation in another clinical study involving an investigational product that in the opinion of the investigator may interfere with the endpoints or investigational criteria of this study;
• Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks, especially inability to understand and fulfill the health-related QOL questionnaire;
• Any history of a definitively ablative procedure for benign prostatic disease, such as benign prostatic hyperplasia, including TURP, whether electrosurgical or thermal laser ablation; or high intensity frequency ultrasound (HIFU) or cryotherapy, for focal or total ablative therapy of the prostate.
• Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure such as:
• Medical conditions that preclude the use of general anesthesia;
• Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of fistula formation;
• Hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production within the previous 6 months;

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Neoplasms; Neoplasms by Site; Prostatic Neoplasms; Carcinoma

Interventions

palladium-bacteriopheophorbide; padeliporfin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jonathan Coleman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: January 13, 2020
• Study Start: March 31, 2020
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: November 13, 2020

Record last verified: 2020-10

Locations

US (1)