Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer

NCT ID: NCT05212857

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2024-09-30

Brief Summary

Oligo-metastatic prostate cancer (OMPCa) is considered as an intermediated state between localized and poly-metastatic disease. Various retrospective studies and prospective clinical trials are carrying out to validate whether patients with OMPCa could benefit from local treatment for both primary and metastatic lesions. The investigators here to conduct a unique clinical trial which OMPCa patients were confirmed by conventional imaging, and received a long-term enhanced systemic therapy accompanied by tumor-directed therapy.

Detailed Description

Recent studies showed that metastatic lesion of prostate cancer may originate from both the primary and the existing metastatic lesion, thus, disease with limited number of metastatic lesions were considered as oligo-metastatic prostate cancer (OMPCa), an intermediated state between localized and poly-metastatic disease. For patients with newly diagnosed OMPCa, serval studies revealed that prostate radiation therapy could improve their clinical outcomes. For patients with oligo-recurrent prostate cancer, they could also be benefit from stereotactic ablative radiation therapy to the metastatic lesion. The investigators thus designed a distinct clinical trial including patients who were confirmed as oligo-metastatic disease by conventional imaging modality (CT, MRI and ECT) rather than PSMA PET-CT. This study also aimed to evaluate the therapeutic effects of tumor-directed treatment under the background of long-term enhanced systemic therapy, including abiraterone, enzalutamide or apalutamide. Here, the investigators proposed that, for patients with de novo oligo-metastatic prostate cancer, enhanced systemic treatment combined with radical treatment of primary lesion and radiotherapy of all accessible metastatic lesions may prolong their survival time without affecting their quality of life.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

systemic treatment combined with radical treatment and radiotherapy

All recruited participants would receive long-term and unified systemic treatment. Systemic treatment is defined as chemical castration plus new-generation anti-androgen therapy.

For the primary lesion:

The preferred local treatment for primary lesion is radical prostatectomy. Patients who refuse surgery or whose tumors cannot be surgically resected after 3 months' systemic treatment could receive radical radiotherapy.

For the metastatic lesion:

Radiotherapy for metastatic lesions would be performed between 4 weeks and 24 weeks after the local treatment for primary lesion. Stereotactic body radiation therapy (SBRT) is preferred, which could treat all the detected lesions at once or in stages.

Group Type: EXPERIMENTAL

Leuprolide acetate

Intervention Type: DRUG

Given subcutaneously or as an injection

Goserelin acetate

Intervention Type: DRUG

Given subcutaneously or as an injection

Triptorelin acetate

Intervention Type: DRUG

Given subcutaneously or as an injection

Degarelix acetate

Intervention Type: DRUG

Given subcutaneously or as an injection

Abiraterone acetate

Intervention Type: DRUG

Given orally

Apalutamide

Intervention Type: DRUG

Given orally

Enzalutamide

Intervention Type: DRUG

Given orally

Local treatment for primary lesion

Intervention Type: PROCEDURE

Radical prostatectomy to remove prostate primary lesion

Radiotherapy for primary lesion

Intervention Type: RADIATION

Radical radiotherapy for primary lesion

Radiotherapy for metastatic lesion

Intervention Type: RADIATION

Stereotactic body radiation therapy or proton and heavy ion radiation therapy is preferred, which could treat all the lesions at once or treat different lesions in stages.

Interventions

Leuprolide acetate

Given subcutaneously or as an injection

Intervention Type: DRUG

Goserelin acetate

Given subcutaneously or as an injection

Intervention Type: DRUG

Triptorelin acetate

Given subcutaneously or as an injection

Intervention Type: DRUG

Degarelix acetate

Given subcutaneously or as an injection

Intervention Type: DRUG

Abiraterone acetate

Given orally

Intervention Type: DRUG

Apalutamide

Given orally

Intervention Type: DRUG

Enzalutamide

Given orally

Intervention Type: DRUG

Local treatment for primary lesion

Radical prostatectomy to remove prostate primary lesion

Intervention Type: PROCEDURE

Radiotherapy for primary lesion

Radical radiotherapy for primary lesion

Intervention Type: RADIATION

Radiotherapy for metastatic lesion

Stereotactic body radiation therapy or proton and heavy ion radiation therapy is preferred, which could treat all the lesions at once or treat different lesions in stages.

Intervention Type: RADIATION

Other Intervention Names

Enantone; Zoladex; Diphereline; Firmagon; ZYTIGA; ERLEADA; Xtandi; Stereotactic body radiation therapy or proton and heavy ion radiation therapy

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed de novo prostate adenocarcinoma (can be accompanied by neuroendocrine differentiation, but accounts for less than 10% of the total tumor components);

2. Aged between 18 and 80;

3. M1a/b disease with presence of 1-5 visible metastases (detected by bone scan (ECT), chest, abdominal and pelvic CT or MRI). Biopsy of the suspected metastases is recommended to the patients. If the patients refused to the biopsy, additional PSMA-PET/CT or regional MRI should be performed to confirm the metastatic lesions.

4. The metastatic lesions should meet the following the criteria:

1. Metastases are limited to bone or lymph nodes;

2. Visceral metastases are not allowed;

3. Radiographic observed pelvic lymph node metastasis with a diameter of >2cm should also be considered as one metastatic lesion.

4. If the lymph nodes are the only detected metastatic lesions, at least one metastatic lymph node should be outside the pelvis.

5. ECOG performance status of 0 or 1;

6. PSA less than 100ng/ml at diagnosis;

7. No more than one month's systemic treatment before enrollment (including castration (surgical or medical castration), castration combined with traditional anti-androgen therapy (flutamide or bicalutamide));

8. No previous pelvic radiotherapy history;

9. The primary lesion of prostate cancer has not received any form of local treatment (surgery, radiotherapy, cryotherapy, radiofrequency ablation, etc.); TURP is allowed, if the aim of the surgery is to relieve lower urinary tract symptom but not to treat the tumor.

10. The metastatic lesions of prostate cancer have not received any form of local treatment (surgery, radiotherapy, cryotherapy, radiofrequency ablation, etc.);

11. Written informed consent;

12. Willing and expected to comply with treatment and follow up schedule.

13. Life expectancy > 10 years.

Exclusion Criteria

1. Received prior local treatment for primary lesion or metastatic lesions, including radical prostatectomy, radical radiotherapy, surgery or radiotherapy to metastatic lesion;

2. Received prior systemic treatment for prostate cancer longer than 1 month;

3. Received prior castration combined with new-generation androgen signaling pathway inhibitors such as abiraterone, apalutamide or enzalutamide; castration combined with docetaxel chemotherapy;

4. Had any visceral metastases (liver, lung, brain etc.);

5. Histologically or cytologically confirmed small cell carcinoma;

6. Unable to tolerate the treatment for primary and metastatic lesion;

7. Unwilling to accept potential related adverse events caused by treatment for primary and metastatic lesion;

8. Had any other previous or current malignant disease, except for curatively treated skin basal cell carcinoma or other tumors cured for more than 5 years;

9. Had other severe disorders, such as:

1. Unstable cardiac disease,

2. Myocardial infarction less than 6 months prior to enrollment,

3. Clinically significant cardiac failure requiring treatment, defined as New York Heart Association (NYHA) class III,

4. Uncontrolled hypertension,

5. Severe neurological or psychological disorder including dementia or epilepsy,

6. Uncontrolled active infection,

7. Acute gastric ulcer,

8. Hypercalcemia,

9. Chronic obstructive pulmonary lung disease requiring hospitalization,

10. Any other significant disorders that in the investigator's opinion means the participant is unfit for any of the study treatments;

10. Had participated in other clinical trial before enrollment.

11. Had contraindications to radiotherapy or unsuitable for radical radiotherapy evaluated by radiologists and physicists.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ding-Wei Ye

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dingwei Ye, Doctoral

Role: STUDY_CHAIR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bo Dai, Doctoral

Role: CONTACT

bodai1978@126.com

8618017312570

Facility Contacts

Dai Bo, Doctor

Role: primary

bodai1978@126.com

8621-64175590

Other Identifiers

OMPCa-ENSURE

Identifier Type: -

Identifier Source: org_study_id