Phase I study of postoperative stereotactic body radiotherapy for prostate cancer

JRCT ID: jRCT1030220062

Registered date:11/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: prostate cancer
• Date of first enrollment: 01/08/2022
• Target sample size: 36
• Study type: Interventional

Intervention(s)

Postoperative stereotactic body radiation therapy for prostate cancer.
The total dose is 35 / 37.5 / 40 Gy in five fractions once a day.
We start with the lowest dose level and gradually increase the dose level while assessing safety.

Outcome(s)

• Primary Outcome: Incidence rate of Grade 3 or higher adverse events that occurred within 90 days after the end of radiation therapy (evaluated by Common terminology Criteria for Adverse Events: CTCAE version 5.0)

Secondary Outcome

1. Incidence rate of adverse events that occurred within 90 days after the end of radiation therapy (evaluated by CTCAE version 5.0)
2. Incidence rate of adverse events that occurred 91 days after the end of radiation therapy (evaluated by CTCAE version 5.0)
3. Incidence rate of patient-reported adverse events (evaluated by Patient-Reported Outcome Common Terminology Criteria for Adverse Events: PRO-CTCAE version 1.0 Japanese translation version by JCOG)
4. QOL: Changes in scores of Expanded Prostate Cancer Index Composite (EPIC) and Functional Assessment of Cancer Therapy-Prostate (FACT-P)
5. Prostate symptoms: Changes in the International Prostate Symptom Score (IPSS)
6. Overall survival
7. Biochemical recurrence-free survival: The biochemical recurrence date is defined as the following.
a. The day when the PSA minimum value + 2 ng/mL was reached after the end of radiation therapy
b. The day when it is determined that salvage treatment such as hormone therapy is necessary

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

a) Patients who undergo radical prostatectomy at our hospital for prostate cancer and will receive radiation therapy as adjuvant or salvage therapy at our hospital.
b) Performance status (PS): 0-2.
c) Over 18 years old.
d) Patients whose pre-registration treatment plan meets the dose constraints.
e) A blood test within 28 days prior to the start of radiation therapy meets all of the following:
WBC > 3,000 /mm3
Hb > 10.0 g/dL
Plt > 75,000 /mm3
eGFR > 60 mL/min/1.73 m2
f) Patients who has given written consent to participate in the study.

Exclude criteria

a) Patients who did not consent to participate in the study.
b) With lymph node metastasis or distant metastasis.
c) With a history of radiation therapy to the pelvis.
d) With inflammatory bowel disease such as ulcerative colitis and Crohn's disease.
e) With a history of rectal surgery.
f) Patients participating in other clinical trials that may affect the conduct or outcome of this study.
g) Patients who are judged to be inappropriate to participate in this study by the principal investigater or co-investigaters.

Related Information

• Primary Sponsor: Yamashita Hideomi