Brief Summary

This is a prospective, interventional pilot study to evaluate the feasibility of randomizing patients diagnosed with prostate cancer to different treatment schemes according to their risk. Patients with a diagnosis of prostate adenocarcinoma (confirmed by biopsy), without signs of metastasis outside the pelvis in the staging study and without prior radiotherapy (RT) to the pelvic region will be recruited. The definition of risk group from the international guide National Comprehensive Cancer Network will be used.

Low risk
Favorable intermediate risk
Unfavorable intermediate risk
High risk The use of hormonal blocking will be at the discretion of each treating physician. The radiotherapy simulation will be carried out according to the institutional protocol for the treatment of prostate cancer. According to the risk group of the patients, the following randomization will be carried out:
Low / intermediate favorable risk: Patients will be randomized to receive SBRT to prostate 36.25 Gy in 5 fractions, alternate days or weekly, with VMAT (technique and 6 Mega-voltage (MV) X-rays vs to SBRT to prostate 26 Gy in 2 fractions, 1 weekly fraction, with VMAT technique and 6 Mv X-rays. The volumes to be treated, ¨Clinical target volume¨ (CTV) will be defined as the prostate, according to the consensus of the Radiation Therapy Oncology Group (RTOG).
Intermediate unfavorable risk and high risk: Patients will be randomized to receive SBRT to the prostate and seminal vesicles, 36.25 Gy in 5 fractions, alternate days or weekly, with VMAT technique and 6 MV X-rays vs SBRT to pelvis scheme of 25 Gy in 5 fractions with simultaneous integrated boost up to 36.25 to the prostate and seminal vesicles, with the same technique.
Patients with positive pelvic node: Will be randomized to moderate hypofractionated RT , completing a dose of 44 Gy in 20 fractions to the pelvis with a simultaneous integrated boost up to 54-60 Gy in 20 fractions to metastatic lymphadenopathy and prostate with seminal vesicles, completing 60 Gy to prostate and seminal vesicles or to ultra hypofractionated RT to the prostate and macroscopic lymphadenopathy to 35 and 30-35 Gy respectively and 25 Gy in 5 fractions to the elective nodal areas.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

June 22, 2021

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed

21 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed

Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

October 27, 2021

Last Update Submit

April 3, 2024

Conditions

Prostatic Neoplasms Radiosurgery Quality of Life

Outcome Measures

Primary Outcomes (3)

Recruitment
Percentage of screened patients eligible recruited
12 months
Treatment protocol fidelity
Percentage of recruited patients receiving treatment according to protocol
12 months
Follow up
Percentage of recruited patients effectively followed according to protocol
12 months

Secondary Outcomes (3)

Biochemical control
24 months
Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organization Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30
6,12 and 24 months
Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains.
6, 12 and 24 months