Prostate SABR With Intra-Prostatic SABR Boost

King Saud University

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Pelvic SABR with intra-prostatic SABR

Study type: Interventional

Funder types: Other

Identifiers

NCT04212715

E-19-4346

Details and patient eligibility

About

Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed prostate adenocarcinoma
• High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
• Willing to give informed consent to participate in this clinical trial

Exclusion criteria

• Prior pelvic radiotherapy
• Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
• Contraindication to prostate MRI
• No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
• Definitive extrapelvic nodal or distant metastatic disease on staging investigations.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental arm

Experimental group

Description:

SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs

Treatment:

Radiation: Pelvic SABR with intra-prostatic SABR