European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up

• Sponsor: Steba Biotech S.A. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04017325
• Collaborator: International Drug Development Institute (Other), ICON plc (Industry)
• Enrollment: 374
• Locations: 36
• Actual Duration (Months): 50.6
• Patients Per Site: 10.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Prostate	Other: no intervention (post study follow up)

Detailed Description

This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). No intervention or further intervention with TOOKAD® Soluble is mandated in this additional 60-month follow-up study where patients in the original TOOKAD® Soluble group and active surveillance (control) group are both managed by their physician as appropriate to their condition using any treatment available following a 'local standard of care' principle from the end of the trial (M24) up to the end of follow-up (M84). Management decisions are entirely left to clinicians and their patients in this pragmatic extension of the trial (no criteria imposed) where standard of care that reflects clinical practice within each centre is applied.

All patients originally randomised in study CLIN1001 PCM301, whether allocated to the TOOKAD® Soluble VTP arm (n=206) or Active surveillance arm (n=207 and who did not withdraw their consent will be included in this extension study.

This extension study consists of 2 different follow-up:

• a follow-up of patients via investigators

• and a follow-up via interviews directly with patients

Study Design

• Study Type: Observational
• Actual Enrollment: 374 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. Post Study 5-year Follow-up
• Actual Study Start Date: Mar 17, 2016
• Actual Primary Completion Date: Jun 3, 2020
• Actual Study Completion Date: Jun 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
TOOKAD VTP TREATMENT Subjects randomized in the treatment arm (TOOKAD VTP treatment) in the initial period of the study.	Other: no intervention (post study follow up); No intervention (post study follow up)
Active surveillance Subjects randomized in the control group (active surveillance) in the initial period of the study.	Other: no intervention (post study follow up); No intervention (post study follow up)

Outcome Measures

Primary Outcome Measures

1. Disease progression [Over the 5 years of follow up]

   Progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men initially randomized to TOOKAD® Soluble VTP compared to men originally randomized on active surveillance.

2. Other prostate cancer therapy [Over the 5 years of follow up]

   Use of other prostate cancer therapy: radical therapy (surgery, radiotherapy, cryotherapy, ultrasound therapy), hormonal therapy or chemotherapy or any therapy indicated for the treatment of prostate cancer in the countries of the study.

3. Prostate cancer-related death. [Over the 5 years of follow up]

   Any death related to Prostate cancer

Secondary Outcome Measures

1. Absence of cancer [Over the 5 years of follow up]

   The proportion of absence of cancer at biopsy (when available)

2. Radical therapy [Over the 5 years of follow up]

   The rate of prostate cancer radical therapy;

3. Cancer burden [Over the 5 years of follow up]

   The total cancer burden in the prostate

4. Urinary incontinence [Over the 5 years of follow up]

   The description of incontinence in terms of mean, median, SD, inter-quartile ranges, min-max

5. Erectile dysfunction [Over the 5 years of follow up]

   The description of erectile dysfunction in terms of mean, median, SD, inter-quartile ranges, min-max

6. Urethral stenosis [Over the 5 years of follow up]

   The rate of urethral stenosis

7. Prostate cancer complication [Over the 5 years of follow up]

   The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death

8. Patients Questionnaires Quality of life [Over the 5 years of follow up]

   Overal Quality of Life will be recorded for potential utility and descriptives studies

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male

Inclusion Criteria:

• All subjects originally randomized in study CLIN1001 PCM301 are included in this follow-up study. As a reminder, they all met the following criteria at entry (from the original protocol):

1. Low risk prostate cancer diagnosed using one trans-rectal ultrasound guided biopsy (TRUS) using from 10 to 24 cores, within 12 months of enrolment and showing the following:

• Gleason 3 + 3 prostate adenocarcinoma as a maximum,

• Two (2) to three (3) cores positive for cancer. Patients with only one positive core can be included provided they have at least 3 mm of cancer core length.

• A maximum cancer core length of 5 mm in any core.

1. Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted).

2. Serum prostate specific antigen (PSA) of 10 ng/mL or less.

3. Prostate volume equal or greater than 25 cc and less than 70 cc.

4. Male subjects aged 18 years or older.

Exclusion Criteria:

• As a reminder, all subjects originally randomized did not met the following criteria at entry (from the original protocol):

1. Unwillingness to accept randomization to either of the two arms of the study.

2. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.

3. Any surgical intervention for benign prostatic hypertrophy.

4. Life expectancy less than 10 years.

5. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.

6. Participation in another clinical study or recipient of an investigational product within 1 month of study entry.

7. Subject unable to understand the patient's information document, to give consent or complete the study tasks. Subject in custody and or in residence in a nursing home or rehabilitation facility.

8. Contra-indication to MRI (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology-Tampere University Hospital-	Tampere		Finland	33521
2	Centre Hospitalier Universitaire (CHU)	Angers		France
3	CHRU Hopital Jean Minjoz	Besançon		France	25030
4	Site Médipole	Cabestany		France	66330
5	Polyclinique Sévigné	Cesson Sévigné		France	35512
6	Hôpital Claude Huriez	Lille		France	59037
7	Hôpital La Conception	Marseille		France	13005
8	Institut Mutualiste Montsouris (IMM)	Paris Cedex 14		France	75674
9	Hôpital Cochin	Paris Cedex 14		France	75679
10	Hôpital Tenon	Paris		France	75020
11	Centre Hospitalier Universitaire Lyon Sud	Pierre-Bénite		France	69495
12	CHU Pontchaillou	Rennes		France	35 033
13	Clinique Urologique Nantes	Saint Herblain		France	44800
14	Marien Krankenahaus GmbH	Bergisch Gladbach		Germany	51465
15	ATURO-Gemeinschaftspraxis für Urologie und Andrologie	Berlin-Wilmersdorf		Germany	D-14197
16	Klinikum Braunschweig	Braunschweig		Germany	38126
17	Universitätsklinikum "Carl Gustav Carus" der Technischen Universität	Dresden		Germany	D-01307
18	Urologische Gemeinschaftspraxis	Emmendingen		Germany	79132
19	Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center	Hamburg		Germany	D-20246
20	Vinzenz Krankenhaus - Department of Urology	Hannover		Germany	30559
21	SLK-Kliniken Heilbronn GmbH	Heilbronn		Germany	74078
22	University Hospital Schleswig-Holstein	Kiel		Germany	D-24105
23	Ludwig-Maximilians-Universität München	Munich		Germany	D - 81377
24	Urologie 24	Nuremberg		Germany	90491
25	Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia	Torino		Italy	10126
26	Netherlands Cancer Institute	Amsterdam		Netherlands	1066 CX
27	Catharina Ziekenhuis	Eindhoven		Netherlands
28	Hospital Universitario de A Coruña	A Coruña		Spain	15006
29	Department of Urology-Hospital Clinic, University of Barcelona	Barcelona		Spain	08036
30	Complejo Hospitalario Regional Virgen Del Rocio-Department Urology	Sevilla		Spain	41013
31	Instituto Valenciano de Oncologia	Valencia		Spain	46009
32	Dept of Urology-University Hospital-	Malmö		Sweden	20502
33	Kings College Hospital (KCH)	London		United Kingdom	SE5 9RS
34	University College London Hospital (UCLH)	London		United Kingdom
35	Oxford John Radcliffe Hospital Trust	Oxford		United Kingdom	OX3 7LJ
36	Royal Hallamshire Hospital	Sheffield		United Kingdom

Sponsors and Collaborators

• Steba Biotech S.A.
• International Drug Development Institute
• ICON plc

Investigators

• Principal Investigator: Mark EMBERTON, Professor, University College of London Hospital , United Kingdom

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steba Biotech S.A.
• ClinicalTrials.gov Identifier: NCT04017325
• Other Study ID Numbers: CLIN1001 PCM301-FU5
• First Posted: Jul 12, 2019
• Last Update Posted: Mar 22, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 22, 2021