Clinical trial · Interventional
Integrated Boost to the Dominant Intraprostatic Nodule Based on Ga-68 PSMA PET/MR Study of SBRT With Prostate Cancer
A Phase I Integrated Boost to the Dominant Intraprostatic Nodule Based on Ga-68 Prostate-Specific Membrane Antigen (PSMA) PET/MR Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to test the safety and efficacy of integrated boost to the dominant intraprostatic nodule based on Ga-68 Prostate-Specific Membrane Antigen (PSMA) PET/MR in Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Simultaneously integrated boost or sequential integrated boost * Simultaneously integrated boost Prostate tumor: starting dose 8.7 Gy per fraction in 5 fractions (total 43.5 Gy) Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions. Total 36.25 Gy. * Sequential integrated boost Prostate tumor: starting dose 7.25 Gy per fraction in 6 fractions (total 43.5 Gy) Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions. Total 36.25 Gy.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
Primary outcomes (1)
- measure
- The Probability of Acute genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction
- timeFrame
- 90 days after the first fraction of radiotherapy treatment
- description
- Acute genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction (ED) (grade 2 or more) according to the NCI CTCAE v4.0.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * tumor clinical stage cT1-3N0M0 according to AJCC TNM 2017 * Without any treatment of prostate cancer including radiotherapy, ADT, chemotherapy, focal treatment, etc. * With the examination of Ga-68 PSMA PET/MR * International Prostate Symptom Score(IPSS)\<15 (alpha blockers allowed), without severe urethral obstruction symptoms * ECOG performance status 0-2 * Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures Exclusion Criteria: * Prior pelvic RT * A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI * Tumor clinical stage cT4, with metastases including bone, lymph nodes or organ metastasis * Histologically confirmed neuroendocrine tumor or small cell carcinoma of the prostate * Severe or active co-morbidity likely to impact on the advisability of SBRT like severe liver or kidney dysfunction, etc. * Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, etc. * Patients who have participated in other clinical trials for less than three months * Patients have acute prostatitis or chronic prostatitis with urinary symptoms * Urine routine indicates obvious urinary system infection and no significant improvement after anti-infective treatment, or conversion to recurrent urinary system infection * Unsuitable to participate in this clinical trial judged by the investigator
References
Publications (1)
- DERIVEDZhao X, Zhu X, Cheng C, Jiang L, Ye Y, Cao Y, Li Y, Zuo C, Zhang H. Protocol of the integrated boost to the dominant intraprostatic nodule in stereotactic body radiation therapy for localized prostate cancer. Future Oncol. 2022 Dec 12. doi: 10.2217/fon-2022-0590. Online ahead of print. PMID 36507781