Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Carcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Hormones

Hormone Antagonists

The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.

The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.

The patients will receive long-term ADT combined with abiraterone.

ADT combined with abiraterone

The patients will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.

neoadjuvant hormone and RT

Huojun Zhang, PhD

Xianzhi Zhao, MD

Di Gu, PhD

Xiang Ding, PhD

Ninghan Feng, PhD

Zejun Yan, PhD

Shancheng Ren, PhD

The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.

The present study will be conducted as a prospective, open-label, two arms clinical trial. Patients with ≤ 3 de novo oligometastatic PCa, diagnosed on Ga-68 prostate-specific membrane antigen (PSMA) PET/CT, will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT). The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone. The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. The primary endpoints of the study are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS). The secondary endpoints include quality of life (QoL), time to CRPC, positive surgical margin (pSM), overall survival (OS), postoperative continence, and toxicities parameters.

Patients will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT).

Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial

Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.

To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).

To assess the time to castration-resistant prostate cancer (CRPC)

Changhai Hospital

Director

Androgens

Patients with de novo oligo-metastatic prostate cancer will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy.

The patients will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy(RT).

hormone and RT

The patients will receive a two-year course of ADT combined with abiraterone.

Zhang Huojun, PHD

Bichun Xu, MD

Zhang Huojun

The existing large prospective study demonstrates the benefits of primary radiotherapy in patients with low-volume oligo-metastatic prostate cancer (OMPC), and there is also more evidence of the benefits of local metastasis-directed therapy (MDT) for metastatic lesions. But there is no results from prospective study to demonstrate the efficacy of radiotherapy for prostate and oligo-metastases. Therefore, the aim of the protocol is to illustrate the efficacy of radiotherapy for prostate and oligo-metastatic lesions in patients with de novo OMPC.

This study involves a single-center, limited-sample, single-arm exploration of radiotherapy for prostate and oligo-metastatic lesions in patients diagnosed with low-volume, hormone-sensitive OMPC. Eligible participants undergo thorough assessments and treatment involving endocrine therapy alongside radiation targeting metastatic lesions and the pelvic region. All patients received radiation therapy for both the primary and metastatic lesions combined endocrine therapy. Endocrine therapy with an antiandrogen (bicalutamide,for 4 weeks) androgen deprivation therapy combined with novel hormonal agents (acetate abiraterone), which will be continued for 2 years. The primary objective is to evaluate progression-free survival-2 (PFS-2), while secondary endpoints include ADT free survival, quality of life (QoL), overall survival, time to castration-resistant prostate cancer (CRPC), radiation-related complications and endocrine therapy related adverse events.

Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer

Efficacy and Safety of Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer: An Open, Exploratory Pilot Clinical Trial

To assess the duration from the reinitiation of endocrine therapy until the identification of disease progression again.

To assess the timeframe between the completion of the initial ADT treatment and the onset of the subsequent ADT treatment.

To evaluate utilizing QoL questionnaires.In the EQ-5D descriptive system five dimensions are assessed: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patients are asked to rate each dimension on a scale ranging from 'no problems'(1) to 'unable to/ extreme problems'(5).The VAS is a vertical scale ranging from 0 to 100 where 0 indicates worst imaginable health and 100 indicates best imaginable health.

To assess the duration from enrollment until death from any cause or the last follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer	NCT05707468	Oligometastatic...	ADT combined wi... neoadjuvant hor...	18 Years - 75 Years	Changhai Hospital
Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer	NCT06198387	Oligo-metastati...	hormone and RT ADT combined wi...	18 Years - 75 Years	Changhai Hospital

Spots Global Cancer Trial Database for adt combined with abiraterone