Trial Outcomes & Findings for Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer. (NCT NCT03315754)

Last Updated: 2024-12-20

Results Overview

Binary response to treatment defined as absence of Gleason grade 4 or 5 on biopsy on 12-month post-treatment following TOOKAD® Soluble VTP in men with Gleason score 7 (3+4) prostate cancer

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

12 months

Results posted on

2024-12-20

Participant Flow

Fifty men presenting with Gleason score 7 (3+4) prostate cancer in at least one lobe were enrolled in the study.

Participant milestones

Participant milestones
Measure	TOOKAD Soluble 4 mg/kg TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds. TOOKAD Soluble 4 mg/kg: Vascular targeted photodynamic therapy using TOOKAD Soluble
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TOOKAD Soluble 4 mg/kg TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds. TOOKAD Soluble 4 mg/kg: Vascular targeted photodynamic therapy using TOOKAD Soluble
Overall Study COVID-19 complications leading to death	1
Overall Study insurance coverage issue	1

Baseline Characteristics

Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TOOKAD Soluble 4 mg/kg n=50 Participants TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds. TOOKAD Soluble 4 mg/kg: Vascular targeted photodynamic therapy using TOOKAD Soluble
Age, Customized Age	61.9 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race/Ethnicity, Customized Race, (%) · Unknown/Not Reported	8 Participants n=5 Participants
Race/Ethnicity, Customized Race, (%) · White	39 Participants n=5 Participants
Race/Ethnicity, Customized Race, (%) · African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race, (%) · Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Race, (%) · American Indian/Alaska Native	1 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants
Number of Participants with Biopsy for Gleason score 7 (3+4) prostate cancer in at least one lobe	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Binary response to treatment defined as absence of Gleason grade 4 or 5 on biopsy on 12-month post-treatment following TOOKAD® Soluble VTP in men with Gleason score 7 (3+4) prostate cancer

Outcome measures

Outcome measures
Measure	TOOKAD Soluble 4 mg/kg n=45 Participants TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds. TOOKAD Soluble 4 mg/kg: Vascular targeted photodynamic therapy using TOOKAD Soluble
Number of Participants With Negative Biopsy for Gleason Grade 4 or 5 Prostate Cancer on 12-month Post-treatment	38 participants

SECONDARY outcome

Timeframe: months 24, 36, 48 and 60

Binary response to treatment defined as the absence of any Gleason grade 4 or 5 biopsy on or before months 24, 36, 48 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of gleason grade 4 or 5, the subject will be considered to have responded;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3, 12, 24, 36 and 60

Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 12, 24, 36, 48 and 60

Binary response to treatment defined as the absence of any Gleason grade 4 or 5 biopsy on or before months 12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of gleason grade 4 or 5, the subject will be considered to have responded;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3, 12, 24, 36, 48 and 60

Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3, 12, 24, 36, 48 and 60

Changes in biopsy parameters (Gleason score) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3, 12, 24, 36, 48 and 60

Changes in biopsy parameters (number of positive score) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 3, 12, 24, 36, 48 and 60

Changes in biopsy parameters (cancer core length) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 1, 3, 6, 12, 24, 36, 48 and 60

Changes in patients' reported outcome measures (PROMs) for urinary symptoms using IPSS (changes in IPSS scores from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months after treatment)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: months 1, 3, 6, 12, 24, 36, 48 and 60

Changes in patients' reported outcome measures (PROMs) for erectile function using IIEF 15 (changes in IIEF 15 scores from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months after treatment)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 60 months

Severe prostate cancer-related events: cancer extension to T3, metastasis or prostate cancer-related death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 60 months

Use of secondary prostate cancer treatment following VTP will include surgical removal of the prostate gland, radiation treatment to the prostate gland, use of hormone or chemotherapies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 60 months

Collection Adverse events

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 1, 3, 6, 12, 24, 36, 48, 60

Serum PSA measurements in ng/mL.

Outcome measures

Outcome data not reported

Adverse Events

TOOKAD Soluble 4 mg/kg

Serious events: 9 serious events

Other events: 50 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	TOOKAD Soluble 4 mg/kg n=50 participants at risk TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds. TOOKAD Soluble 4 mg/kg: Vascular targeted photodynamic therapy using TOOKAD Soluble
Infections and infestations COVID-19	11.1% 1/9 • Number of events 1 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Surgical and medical procedures Total knee replacement	22.2% 2/9 • Number of events 2 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 1 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Gastrointestinal disorders Vomiting	11.1% 1/9 • Number of events 1 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
General disorders Chills	11.1% 1/9 • Number of events 1 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Musculoskeletal and connective tissue disorders Flank pain	11.1% 1/9 • Number of events 1 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.

Other adverse events

Other adverse events
Measure	TOOKAD Soluble 4 mg/kg n=50 participants at risk TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds. TOOKAD Soluble 4 mg/kg: Vascular targeted photodynamic therapy using TOOKAD Soluble
Renal and urinary disorders Micturition urgency	76.0% 38/50 • Number of events 42 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Renal and urinary disorders Pollakiuria	74.0% 37/50 • Number of events 41 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Renal and urinary disorders Hematuria	66.0% 33/50 • Number of events 37 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Renal and urinary disorders Urinary tract pain	62.0% 31/50 • Number of events 33 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Renal and urinary disorders Urinary incontinence	18.0% 9/50 • Number of events 9 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Renal and urinary disorders Urinary tract obstruction	14.0% 7/50 • Number of events 7 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Renal and urinary disorders Urinary retention	8.0% 4/50 • Number of events 4 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Reproductive system and breast disorders Erectile dysfunction	46.0% 23/50 • Number of events 25 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Reproductive system and breast disorders Haematospermia	30.0% 15/50 • Number of events 17 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Reproductive system and breast disorders Perineal pain	16.0% 8/50 • Number of events 8 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Reproductive system and breast disorders Edema genital	8.0% 4/50 • Number of events 4 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Reproductive system and breast disorders Retrograde ejaculation	6.0% 3/50 • Number of events 3 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Gastrointestinal disorders Constipation	44.0% 22/50 • Number of events 24 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Gastrointestinal disorders Diarrhoea	10.0% 5/50 • Number of events 7 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Gastrointestinal disorders Proctalgia	6.0% 3/50 • Number of events 3 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
General disorders Pain	32.0% 16/50 • Number of events 19 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
General disorders Fatigue	20.0% 10/50 • Number of events 10 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
General disorders Pyrexia	10.0% 5/50 • Number of events 6 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
General disorders Chills	6.0% 3/50 • Number of events 4 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Infections and infestations Infections and infestations	22.0% 11/50 • Number of events 13 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Reproductive system and breast disorders Epididymitis	6.0% 3/50 • Number of events 4 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	22.0% 11/50 • Number of events 13 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.
Injury, poisoning and procedural complications Contusion	20.0% 10/50 • Number of events 11 • 12 months All patients experienced at least one AE during the first 12 months period of this study. A total of 379 AEs were reported, none which were related to the study drug.

Additional Information

Jonathan Coleman, MD

Memorial Sloan Kettering Cancer Center, New York, NY, USA

Phone: +1-646-422-4432

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place