Phase II clinical trial of hypofractionated image-guided proton beam therapy for loalized prostate cancer

JRCT ID: jRCT1032240350

Registered date:26/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 26/09/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Proton therapy with 51.6 Gy Relative biological effectiveness (RBE) in 12 fractions with a fractional dose of 4.3Gy RBE (4 times per week)

Outcome(s)

• Primary Outcome: Incident rates of late adverse event

Secondary Outcome

1)Incident rates of acute and late adverse events stratified by severity
2)5-year cumulated biochemical recurrence rate
3)5-year cumulated overall survival rate
4)5-year cumulated disease-specific survival rate
5)5-year cumulated clinical recurrence rate
6)Patient-reported outcome measures (PROMs), EQ-5D-5L, QLQ-30C
7)G8

Key inclusion & exclusion criteria

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

Include criteria

1)Written consent has been obtained from the patient to parcitipate in the study.
2)Age at the time of consent is 18 years or older.
3)Performance status of Eastern Cooperative Oncology Group is 0-2.
4)Primary prostate cancer (adenocarcinoma according to the 4th edition of the Clinical Practice Guideline for Prostate Cancer or acinar adenocarcinoma to the 5th edition) is diagnosed based on tissue diagnosis from the prostate gland.
5)Based on tphysical findings or CT/MRI/bone scintigraphy, the cliniccal stage is T1c-3aN0M0 according to the 8th edition of the UICC/TNM classification.
6)Placement of hydrogel spacer is feasible.

Exclude criteria

1)Patients with serious complications (severe infection, heart failure, acute myocarrdial infarction, respiratory failure, liver failure, renal failure, acute cerebrovascular disorder, poorly controlled diabetes).
2)Patients with active multiple cancers at the time of informed consent. Synchronous multiple cancers and metachronous multiple cancers with a disease-free period of five years or less are defined as active multiple cancers. However, clinical stage 0 or I laryngeal cancer that has achieved a complete response after radiation therapy was excluded. In addition, a history of completely resected cancer with a 5-year relative survival rate of 95% or higher, such as cancer at the following pathological stages is not included in active multiple cancers.
Gastric cancer "adenocarcinoma (general type)": stage 0-I, rectal cancer (adenocarcinoma): stage 0-I, esophageal cancerr (squamous cell carcinoma, adenosquamous carcinoma, basoloid carcinoma): stage 0, breast cancer (ductal carcinoma in situ, lobular carcinoma in situ): stage0, breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): stage 0-IIA, thyroid cancer (papillary carcinoma, follicular carcinoma): stage I, II, III, renal cancer (clear cell carcinoma, chromophobe ccell carcinoma): stage I, lesions equivalent to other intramucosal cancers.
* Disease staging will, in principle, follow the UICC-TNM 8th edition or equivalent Clinical Practice Guideline for Prostate Cancer.
3)Patients with refractory inflammatory diseases in the irradiated area.
4)Patients with inflammatory diseases requiring systemic treatment.
5)Patients with a history of transurethral resection within six months of obtaining consent.
6)Patients with a history of radiation therapy in the pelvic area.
7)Patients who are unable to understand the treatment due to severe dementia, etc.
8)Patients with a history of invasive treatment for benign prostatic hyperplasia or prostate cancer.
9)Patients with metal allergies in which a marker cannot be inserted.
10) Other patients who the clinical investigator, etc. deems unsuitable for participation in this study.

Related Information

• Primary Sponsor: SAKURAI HIDEYUKI
• Source(s) of Monetary Support: University of Tsukuba