Technical Feasibility of a Randomized Pilot Study of Radiosurgery for the Treatment of Non-metastatic Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histology confirmed prostate cancer

• Disease confined to the pelvis by imaging CT (CT scan of chest, abdomen and pelvis and bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines)

• Eastern Cooperative Oncology Group (ECOG) performance 0-1

• Eligible for curative radiotherapy

Locations
Other Locations
Chile
Pontificia Universidad Catolica de Chile
RECRUITING
Santiago
Contact Information
Primary
Tomas Merino, MD
tmerino@med.puc.cl
56-223543346
Time Frame
Start Date: 2021-06-22
Estimated Completion Date: 2024-06-22
Participants
Target number of participants: 60
Treatments
Experimental: Low-Intermediate favorable risk 5 Fraction SBRT arm
36.25 Gy in 5 fractions to the prostate weekly or every other day
Experimental: Low-Intermediate favorable risk 2 Fraction SBRT arm
26 Gy in 2 fractions to the prostate
Experimental: Intermediate unfavorable-high risk prostate only SBRT arm
36.25 Gy in 5 fractions to the prostate and seminal vesicles base, weekly or every other day
Experimental: Intermediate unfavorable-high risk prostate and pelvis SBRT arm
25 Gy in 5 fractions to the elective pelvic nodes and simultaneous integrated boost to 36.25 Gy in 5 fractions to the prostate and seminal vesicles base, weekly
Experimental: Pelvic node positive moderate hypofractionated radiotherapy
44 Gy in 20 daily fractions to the elective pelvic nodes and simultaneous integrated boost to 60 Gy to the prostate and seminal vesicles base and 54 Gy to positive lymph nodes
Experimental: Pelvic node positive moderate ultra-hypofractionated radiotherapy
25 Gy in 5 fractions to the elective pelvic nodes and simultaneous integrated boost to 36.25 Gy in 5 fractions to the prostate and seminal vesicles base and to 30 Gy to positive lymph nodes.
Sponsors
Leads: Pontificia Universidad Catolica de Chile

This content was sourced from clinicaltrials.gov