Trial Outcomes & Findings for VMAT for Dominant Intraprostatic Lesion (NCT NCT03030625)

NCT ID: NCT03030625

Last Updated: 2024-07-03

Results Overview

Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

5 years

Results posted on

2024-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	IGRT/VMAT Focal Therapy Boost to DIL Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IGRT/VMAT Focal Therapy Boost to DIL n=30 Participants Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy
Age, Continuous	72.0 years n=30 Participants
Sex: Female, Male Female	0 Participants n=30 Participants
Sex: Female, Male Male	30 Participants n=30 Participants
Region of Enrollment Spain	30 Participants n=30 Participants
Clinical T stage T2: Tumor confinent whitin prostate	23 Participants n=30 Participants
Clinical T stage T3: Tumor extends through the prostate capsule	7 Participants n=30 Participants
Gleason group (ISUP 2014/WHO 2016) Group 1:	6 Participants n=30 Participants
Gleason group (ISUP 2014/WHO 2016) Group 2	13 Participants n=30 Participants
Gleason group (ISUP 2014/WHO 2016) Group 3	7 Participants n=30 Participants
Gleason group (ISUP 2014/WHO 2016) Group 4	2 Participants n=30 Participants
Gleason group (ISUP 2014/WHO 2016) Group 5	2 Participants n=30 Participants
Pre-treatment PSA (ng/ml)	8.5 ng/ml n=30 Participants

PRIMARY outcome

Timeframe: 5 years

Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)

Outcome measures

Outcome measures
Measure	IGRT/VMAT Focal Therapy Boost to DIL n=30 Participants Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy: 35 daily fractions of 2.17 Gy with a concomitant focal boost to the intraprostatic nodule of 2.43 Gy
Number of Participants With Biochemical Failure at 5 Years Yes	0 Participants
Number of Participants With Biochemical Failure at 5 Years No	30 Participants

PRIMARY outcome

Timeframe: 6 and 9 months following radiotherapy

An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.

Outcome measures

Outcome measures
Measure	IGRT/VMAT Focal Therapy Boost to DIL n=30 Participants Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy: 35 daily fractions of 2.17 Gy with a concomitant focal boost to the intraprostatic nodule of 2.43 Gy
Local Control Yes	30 Participants
Local Control No	0 Participants

PRIMARY outcome

Timeframe: 5 years

Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).

Outcome measures

Outcome measures
Measure	IGRT/VMAT Focal Therapy Boost to DIL n=30 Participants Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy: 35 daily fractions of 2.17 Gy with a concomitant focal boost to the intraprostatic nodule of 2.43 Gy
Acute and Late Rectal and Urinary Complications Acute rectal · Grade 1	2 Participants
Acute and Late Rectal and Urinary Complications Acute rectal · Grade 0	28 Participants
Acute and Late Rectal and Urinary Complications Acute rectal · Grade 2	0 Participants
Acute and Late Rectal and Urinary Complications Acute rectal · Grade >2	0 Participants
Acute and Late Rectal and Urinary Complications Acute urinary · Grade 0	11 Participants
Acute and Late Rectal and Urinary Complications Acute urinary · Grade 1	13 Participants
Acute and Late Rectal and Urinary Complications Acute urinary · Grade 2	6 Participants
Acute and Late Rectal and Urinary Complications Acute urinary · Grade >2	0 Participants
Acute and Late Rectal and Urinary Complications Late rectal · Grade 0	27 Participants
Acute and Late Rectal and Urinary Complications Late rectal · Grade 1	3 Participants
Acute and Late Rectal and Urinary Complications Late rectal · Grade 2	0 Participants
Acute and Late Rectal and Urinary Complications Late rectal · Grade >2	0 Participants
Acute and Late Rectal and Urinary Complications Late urinary · Grade 0	27 Participants
Acute and Late Rectal and Urinary Complications Late urinary · Grade 1	3 Participants
Acute and Late Rectal and Urinary Complications Late urinary · Grade 2	0 Participants
Acute and Late Rectal and Urinary Complications Late urinary · Grade >2	0 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Localized prostate cancer (PCa) of intermediate and high risk

Biochemical disease-free survival according to the Phoenix definition (PSA \>2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.

Outcome measures

Outcome measures
Measure	IGRT/VMAT Focal Therapy Boost to DIL n=30 Participants Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy: 35 daily fractions of 2.17 Gy with a concomitant focal boost to the intraprostatic nodule of 2.43 Gy
Number of Participants Free of Biochemical Progression	30 Participants

SECONDARY outcome

Timeframe: 5 years

Population: No clinical data were collected for this outcome.

Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Survival free of any event including biochemical failure, local failure, distant metastasis or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula

Outcome measures

Outcome data not reported

Adverse Events

IGRT/VMAT Focal Therapy Boost to DIL

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IGRT/VMAT Focal Therapy Boost to DIL n=30 participants at risk Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria IGRT/VMAT focal therapy boost to DIL: Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy
Gastrointestinal disorders Acute rectal toxicity	6.7% 2/30 • Number of events 2 • 5 years
Renal and urinary disorders Acute urinary toxicity	63.3% 19/30 • Number of events 19 • 5 years
Gastrointestinal disorders Late rectal toxicity	10.0% 3/30 • Number of events 3 • 5 years
Renal and urinary disorders Late urinary toxicity	10.0% 3/30 • Number of events 3 • 5 years

Additional Information

Dr. Almudena Zapatero Laborda

Hospital Universitario de La Princesa

Phone: +34 915 20 22 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place