Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Radiotherapy to prostate and all metastases: Radiotherapy to prostate and all metastases
Prostate: Technique: SBRT
Dose in prostate: 36.25 Gy/ 5 fractions alternate days
Radiotherapy to
Sponsors
Intramural Tata memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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) â�¥ 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 â�¥ 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 â�¤ 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month progression free survival (Serum PSA and/or clinical progression)Timepoint: 12-month progression free survival (Serum PSA and/or clinical progression) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Acute toxicity Timepoint: 12 months for OS 3 months for acute toxicity | — |
Countries
India
Contacts
Public ContactPrashanth Giridhar
MPMMCC/HBCH
Outcome results
None listed