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JCOG2011: A randomized controlled phase III trial for confirming superiority of local radiotherapy added to anti-androgen therapy for prostate cancer patients with high volume metastasis sensitive to hormone therapy (HimeRT study)

JCOG2011: A randomized controlled phase III trial for confirming superiority of local radiotherapy added to anti-androgen therapy for prostate cancer patients with high volume metastasis sensitive to hormone therapy (HimeRT study)

KAMOTO Toshiyuki

University of Miyazaki Hospital

Kihara-5200, Kiyotakecho, Miyazaki city, Miyazaki

tkampro@med.miyazaki-u.ac.jp

MURASHIMA Takaya

University of Miyazaki Hospital

Kihara-5200, Kiyotakecho, Miyazaki city, Miyazaki

+81-985-85-2968

takaya_murashima@med.miyazaki-u.ac.jp

Recruiting

Mar. 02, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

<Primary registration>
1) Histologically diagnosed as acinar adenocarcinoma by prostate needle biopsy
2) One of the following <1><2> in the imaging test before the primary registration.
<1> Bone metastasis is confirmed by bone scintigraphy and meets all of the following i) and ii).
i) The number of bone metastases is 4 or more.
ii) 1 or more bone metastatic lesion outside the pelvis and vertebral bodies.
<2> Visceral metastasis (other than bone, lymph nodes, and skin) is observed on contrast-enhanced CT.
3) Males aged 18 years or older.
4) ECOG Performance status 0 to 2.
5) No ADT or within 84 days (12 weeks) from ADT start. If ADT has been started before the primary registration, one of the following <1> or <2>.
<1>All of the following i) and ii) when ADT with drugs is performed.
i) Goserelin, leuprorelin, or degarelix is not discontinued at primary enrollment.
ii) Within 84 days (12 weeks) from the day of the first administration of ADT.
<2> Within 84 days (12 weeks) from the day of the bilateral orchiectomy as ADT.
6) ARAT (abiraterone + prednisolone, enzalutamide, apalutamide) has not been administered.
7) presence or absence of measurable lesions does not matter.
8) No history of administration of docetaxel for prostate cancer.
9) No history of local surgical treatment or radiotherapy for prostate cancer. However, if there is a history of radiation to bone metastases in the pelvic region or testicular tumor, consult with a radiologist/radiation oncologist to ensure that the total radiation dose is less than a limited dose for each organ.
10) Adequate function of major organs.
11) Written informed consent.

<Secondary registration>
1) After the primary registration protocol treatment was not discontinued by the date of the secondary registration.
2) The cumulative days of ARAT administration (total number of administration days) after primary registration is 84 days or more.
3) All of the following <1> and <2>.
<1> No exacerbation of the primary disease was observed in any of the evaluations.
<2> Neither "suspected progression of bone lesions" nor "suspected progression of PSA".
4) From 168 days (24 weeks) to 196 days (28 weeks) from the primary registration date.
5) The date of secondary registration is 28 days (4 weeks) from the date of second imaging evaluation.
6) Performance status is 0 to 2.
7) Adequate function of major organs.

1) Synchronous or metachronous (within 5 years) malignancies.
2) Infectious disease requiring systemic treatment.
3) Pyrexia of 38 or higher degrees centigrade.
4) Poorly controlled hypertension.
5) Male expecting partner's pregnancy.
6) Severe psychological disorders.
7) Patients receiving systemic steroids or other immunosuppressive drugs.
8) Positive HIV antigen.

Male

high volume metastatic prostate cancer

Arm A (Standard arm): Anti-androgen therapy(ADT+ARAT).
Arm B (Test arm):Anti-androgen therapy(ADT+ARAT)+local radiotherapy(57Gy)

failure-free survival

overall survival, progression-free survival, chemotherapy-free survival, adverse event rate, severe adverse event rate, grade 2 or higher symptomatic local event rate

+81-3-3542-2511

Dec. 22, 2022

Yes

Individual patient-level-data will be provided only when the data is used in collaborative research with JCOG researchers and after the primary analysis result of this tral is published. The JCOG study group chair will make the final decision whether data sharing should be accepted or not. Data sharing information will be released at the JCOG website. JCOG Data Center will receive program, log, and output for the analysis.

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