Radiotherapy to all involved sites in advanced prostate cancer
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2022/10/046239
- Lead Sponsor
- Intramural Tata memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Metastatic prostate cancer (Oligo-metastases i.e. metastases)
Patient must have 1-5 asymptomatic/ mildly symptomatic metastatic tumor(s) of the bone and soft tissue /liver/ lung/ lymph node developed that are amenable for SABR.
Patient must not have had their primary tumor treated with radiation.
Histologic confirmation of malignancy (primary or metastatic tumor).
Prostate specific antigen (PSA) � 0.5 ng/mL
Hormone sensitive and castration resistant prostate cancer
PSMA PET not older than 2 months from randomization
Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer.
Patient must be � 18 years of age, have the ability to understand, and the willingness to sign, a written informed consent document.
Patient must have an Eastern Cooperative Oncology Group performance status � 2.
Patient must have normal organ and marrow function as defined as: Leukocytes >2,000/�¼L, absolute neutrophil count >1,000/�¼L, platelets >50,000/�¼L
No more than 3 years of ADT is allowed
Spinal cord compression or impending spinal cord compression.
Suspected pulmonary and/or liver metastases not amenable for SABR
Receipt of any other investigational agents or participation in a concurrent treatment protocol
Large TURP defects
Moderate-severe urinary symptoms (e.g. high IPSS score, typically defined as IPSS > 20)
Excessive artefact not allowing proper localization of prostate e.g. Hip replacement
Serum creatinine and total bilirubin > 3 times the upper limit of normal
Liver Transaminases > 5-times the upper limit of normal or intractable ascites
Inability to lie flat during or tolerate PET/CT, PET/MRI or SABR.
Refusal to sign informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12-month progression free survival (Serum PSA and/or clinical progression)Timepoint: 12-month progression free survival (Serum PSA and/or clinical progression)
- Secondary Outcome Measures
Name Time Method Overall survival <br/ ><br>Acute toxicity <br/ ><br>Timepoint: 12 months for OS <br/ ><br>3 months for acute toxicity