Primary metastatic prostate cancer with osseous and lymphonodal metastases
Conditions
Interventions
Group 1: Patients with primary metastasized prostate cancer to bone and lymph nodes, who show an insufficient PSA-response of >0,2 ng/ml after 6 months of dual antihormonal therapy (ADT+NHT) and who e
Sponsors
Universitätsklinik für Radioonkologie und Strahlentherapie, Eberhard-Karls Universität Tübingen
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: -written consent -ECOG 0-2 -Prostate adenocarcinoma, confirmed by biopsy -Primary oligo-/polymetastasized prostate cancer (4 or more osseous metastases) without organ metastases, lymphonodal metastases allowed -First line dual antihormonal therapy (androgen deprivation therapy, ADT) + X (X = e.g. Enzalutamide / Abiraterone / Apalutamide or other) according to urologists' recommendation for at least 6 months -imaging at time of diagnosis showing osseous metastases without visceral metastases -insufficient PSA-response of >0,2 ng/ml after 6 months of dual antihormonal therapy -= 15 active osseous lesions in PSMA-PET/CT imaging after 6 months dual antihormonal treatment
Exclusion criteria
Exclusion criteria: - sufficient PSA-response of < 0,2 ng/ml - M1c (visceral metastases) - other active tumor (except basal cell carcinoma/melanoma in remission) - TUR-P or HIFU less than 6 monaths prior to radiotherapy, prior prostatectomy - prior radiotherapy to the pelvis - serious pre-exsisting gastrointestinal conditions (e.g. active fistula, chronic inflammatory bowel disease) - tumor predisposition syndrome - serious pre-exsisting urogenital conditions - contraindication for PSMA-PET/CT imaging - cantraindication for radiotherapy - prior irradiation compromising local ablative radiotherapy of metastases - for T4 stage: Persisting infiltration of rectal mucosa after 6 months of dual antihormonal therapy; critical evaluation in case of bladder infiltration - PSA-progression between first diagnosis and study screening - disease progression necessitating change of systemic therapy or start of chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Decrease in PSMA-volume of at least 30% in PSMA-PET/CT as determined according to RECIP criteria When: 12 Months after metastasis-directed radiotherapy Determined by PSMA-PET/CT as compared to initial PSMA-PET/CT | — |
Secondary
| Measure | Time frame |
|---|---|
| •PSA progression •Lesion-specific response of irradiated metastases in PSMA-PET imaging •Objective response rate, ORR •Interval to next systemic therapy •Overall Survival, OS •Failure-free survival, FFS •Progression-free survival, PFS •Metastasis-free survival, MFS •prostate cancer specific survival, PCS Explorative endpoints: •reason for switching systemic treatment •choice of next systemic treatment •Toxicities (according to CTCAEv5 and RTOG), quality of life (EORTC QLQ-C30 Prostate, QLQ-PR25, EQ-D5), organ function (gastrointestinal and urogenital: IPSS-Score, ICIQ-Score, NCI-PRO-CTCAE, IIEF) | — |
Countries
Germany
Contacts
Public ContactElgin Hoffmann
Universitätsklinik für Radioonkologie und Strahlentherapie, Eberhard-Karls Universität Tübingen
Outcome results
None listed