5 Fractions of Pelvic SABR With Intra Prostatic SABR (5STAR)

Andrew Loblaw

Status

Unknown

Conditions

Prostate Cancer

Treatments

Radiation: Pelvic SABR with intra-prostatic SABR

Study type

Interventional

Funder types

Other

Identifiers

NCT02911636

360-2016

Details and patient eligibility

About

Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT

Full description

SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule

Enrollment

30 estimated patients

Sex

Male

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed prostate adenocarcinoma (centrally reviewed)
High- tier intermediate risk defined as:

PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 )

• High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA > 20 ng/mL

Willing to give informed consent to participate in this clinical trial
Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire

Exclusion criteria

Prior pelvic radiotherapy
Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
Contraindication to prostate MRI
Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
Diagnosis of bleeding diathesis
Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT.
Previous TURP
Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
Significant medical co-morbidity rendering patient unsuitable for general anesthetic
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.