Stereotactic Radiotherapy of Prostate Cancer With Reduction of Safety Margins

Recruiting now · Not applicable

Conditions studied: Prostate Cancer (Adenocarcinoma)

In brief

The study aims to reduce the PTV (Planning Target Volume) safety margins to 1-2 mm in stereotactic prostate radiotherapy for low- and medium-risk prostate cancers while maintaining a dose of 36.25 Gy in 5 fractions per day. By reducing the hems, the investigators expect a reduction of acute and late toxicity on the organs at risk, dominantly the urethra, bladder, penile bulb, and rectum, and an improvement in the quality of life.

Key facts

Study ID

NCT06665932

Run by

University Hospital Ostrava

People needed

100

Starts

2024-11-01

Expected to finish

2027-12-31

Last updated by the study team

2024-11-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• histologically verified, localized prostate cancer without regional lymphadenopathy or distant metastases
• low or intermediate risk - favorable risk
• staging according to NCCN recommendations:
• low risk: no staging required
• intermediate risk- favorable risk: CT abdomen and pelvis
• PSA up to 15
• age over 18 years
• signed informed consent form
• suitable position of fiducials (to be determined by the physicist)

You may not qualify if…

• a histological type other than acinar adenocarcinoma
• the presence of local lymphadenopathy or distant metastases
• a dominant lesion in the periphery that is in contact with the capsule or grows through it
• PSA over 15
• unsatisfactory position of fiducials (to be determined by the physicist)
• previous treatment with radiotherapy to the pelvic area

Where it is running

• University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (enrolling)

Full record on ClinicalTrials.gov

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