A Phase II Trial of 4 fractions of CIRT for Intermediate-risk Prostate Cancer

JRCT ID: jRCT1032220391

Registered date:18/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 13/06/2023
• Target sample size: 212
• Study type: Interventional
• Intervention(s): Protocol treatment consists of once-daily carbon-ion radiotherapy. The dose will be 10 Gy relative biological effectiveness per dose, 4 times/2 weeks (twice a week) for a total dose of 40 Gy (RBE). Non-uniform irradiation with a reduction of 10% of the prescribed dose is performed for 5 mm around the urethra. Carbon-ion radiotherapy should be initiated within 210 days after the 121st day from the date of initiation of hormone therapy.

Outcome(s)

• Primary Outcome: 5-year biochemical relapse-free survival
• Secondary Outcome: Acute and late adverse events, overall survival rate, clinical disease-free survival rate, and QOL evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1) Histologically diagnosed untreated prostate cancer (cases in which hormonal therapy has been initiated after histological diagnosis are acceptable).
2) The patient with intermediate-risk prostate cancer in NCCN the classification of NCCN. The patient has one or more risk factors; T2b-2c disease in the 2017 UICC TNM classification (8th edition), Gleason score = 7 (Grade group 2-3), PSA: 10-20 ng/ml. The patient has none of the risk factors corresponding to high risk; T3a or higher, Gleason score >= 8 [Grade group >= 4], PSA >20 ng/ml), and PSA >20 ng/ml.
The patient has been diagnosed with N0M0 by MRI, CT, and bone scintigram.
3) Patients with 20-year-old or elderly.
4) Patients with a Performance Status (ECOG) of 0-1.
5) Patients who are expected to survive more than 180 days.
6) Patients who have obtained written consent from themselves to participate in this study.
*Any imaging studies before treatment should be performed within 120 days before obtaining consent. If hormone therapy has already been started, a decision using imaging studies within 120 days before the start of hormone therapy is acceptable. Other clinical examinations and judgments regarding performance status should be made within 30 days before obtaining consent. Biopsy specimens should be taken within one year before obtaining consent.
*Hormone therapy will continue until the start of carbon-ion radiotherapy. The start date of carbon-ion radiotherapy will be 121 days after the start of hormone therapy, but no later than 210 days after the start of hormone therapy.
*If the above criteria are met after Active surveillance or by reevaluation after follow-up, the patient may be registered.

Exclude criteria

1) Patients who receive treatment other than the prescribed hormone therapy or have received hormone therapy for more than 210 days.
*If the start date of carbon-ion radiotherapy is expected to be after 211 days from the start date of hormone therapy, the patient will not be enrolled in this study. In addition, castration will be considered a "treatment other than prescribed hormone therapy."
2) Patients with a history of radiotherapy to the region to be irradiated.
3) Patients considered to have castration-resistant prostate cancer.
4) Patients who have undergone transurethral resection of the prostate (TUR-P).
5) Active cancer(s) in other organs (simultaneous cancers and cancers with a disease-free interval of 2 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma considered curable by local treatment are not included in active cancers.
6) Patients with refractory infectious or inflammatory diseases in the region to be irradiated.
7) Patients whose region to be irradiated includes artificial objects such as artificial joints and for whom it is judged that a change in the beam direction will be necessary.
8) Patients whose tumor is clearly in contact with the urethra on diagnostic imagings.
9) Patients deemed ineligible due to medical or psychological factors.
*The insertion of spacers for the treatment of prostate cancer and the insertion of metal markers are not restricted.

Related Information

• Primary Sponsor: Ishikawa Hitoshi