Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer (PCM304)

Steba Biotech

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: TOOKAD® Soluble

Study type

Interventional

Funder types

Other

Identifiers

NCT01875393

CLIN1201 PCM304

Details and patient eligibility

About

The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.

Full description

The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.

Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.

Enrollment

81 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically proven localized prostate carcinoma diagnosed using prostate biopsy showing:
- Gleason 3+3 prostate
- Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.
Clinical stage up to cT2a - N0/Nx - M0/Mx.
Serum prostate-specific antigen (PSA) ˂ 20ng/ml
Prostate volume ≥ 25 cc and ≤ 70 cc.
Male subjects aged 18 years or older.
Signed Informed Consent Form by the patient.

Exclusion criteria

Unwillingness to accept the treatment.
Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy)or chemotherapy.
Any surgical intervention for benign prostatic hypertrophy.
Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
Life expectancy less than 10 years.
Participation in another clinical study involving an investigational product within 1 month before study entry.
Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire.
Subject in custody and or in residence in a nursing home or rehabilitation facility.
Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;
Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;
Any history of urethral stricture disease;
Any history of acute urinary retention within 6 months of study entry