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

NCT05212857 | Unknown Phase 2

• 1 other identifier: OMPCa-ENSURE
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; radical prostatectomy; androgen deprivation therapy; local treatment; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Two years' radiographic progression-free survival (rPFS)

  Proportion of patients without radiographic progression after two years' treatment. The soft-tissue lesion evaluation criterion was RECIST1.1, and the bone lesion evaluation criterion was PCWG3

  2 years

Secondary Outcomes (3)

• Two years' overall survival (OS)

  2 years

• Two years' PSA progression-free survival (PSA-PFS)

  2 years

• Pathological complete response (pCR) or minimal residual disease (MRD) rate

  1 month after prostatectomy as local treatment for primary lesion.

Study Arms (1)

systemic treatment combined with radical treatment and radiotherapy

EXPERIMENTAL

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.

Drug: Leuprolide acetate; Drug: Goserelin acetate; Drug: Triptorelin acetate; Drug: Degarelix acetate; Drug: Abiraterone acetate; Drug: Apalutamide; Drug: Enzalutamide; Procedure: Local treatment for primary lesion; Radiation: Radiotherapy for primary lesion; Radiation: Radiotherapy for metastatic lesion

Interventions

Leuprolide acetate DRUG

Given subcutaneously or as an injection

Also known as: Enantone

systemic treatment combined with radical treatment and radiotherapy

Goserelin acetate DRUG

Given subcutaneously or as an injection

Also known as: Zoladex

systemic treatment combined with radical treatment and radiotherapy

Triptorelin acetate DRUG

Given subcutaneously or as an injection

Also known as: Diphereline

systemic treatment combined with radical treatment and radiotherapy

Degarelix acetate DRUG

Given subcutaneously or as an injection

Also known as: Firmagon

systemic treatment combined with radical treatment and radiotherapy

Abiraterone acetate DRUG

Given orally

Also known as: ZYTIGA

systemic treatment combined with radical treatment and radiotherapy

Apalutamide DRUG

Given orally

Also known as: ERLEADA

systemic treatment combined with radical treatment and radiotherapy

Enzalutamide DRUG

Given orally

Also known as: Xtandi

systemic treatment combined with radical treatment and radiotherapy

Local treatment for primary lesion PROCEDURE

Radical prostatectomy to remove prostate primary lesion

systemic treatment combined with radical treatment and radiotherapy

Radiotherapy for primary lesion RADIATION

Radical radiotherapy for primary lesion

systemic treatment combined with radical treatment and radiotherapy

Radiotherapy for metastatic lesion 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.

Also known as: Stereotactic body radiation therapy or proton and heavy ion radiation therapy

systemic treatment combined with radical treatment and radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Aged between 18 and 80;
• 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.
• The metastatic lesions should meet the following the criteria:
• Metastases are limited to bone or lymph nodes;
• Visceral metastases are not allowed;
• Radiographic observed pelvic lymph node metastasis with a diameter of \>2cm should also be considered as one metastatic lesion.
• If the lymph nodes are the only detected metastatic lesions, at least one metastatic lymph node should be outside the pelvis.
• ECOG performance status of 0 or 1;
• PSA less than 100ng/ml at diagnosis;
• 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));
• No previous pelvic radiotherapy history;
• 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.
• The metastatic lesions of prostate cancer have not received any form of local treatment (surgery, radiotherapy, cryotherapy, radiofrequency ablation, etc.);
• Written informed consent;

You may not qualify if:

• Received prior local treatment for primary lesion or metastatic lesions, including radical prostatectomy, radical radiotherapy, surgery or radiotherapy to metastatic lesion;
• Received prior systemic treatment for prostate cancer longer than 1 month;
• Received prior castration combined with new-generation androgen signaling pathway inhibitors such as abiraterone, apalutamide or enzalutamide; castration combined with docetaxel chemotherapy;
• Had any visceral metastases (liver, lung, brain etc.);
• Histologically or cytologically confirmed small cell carcinoma;
• Unable to tolerate the treatment for primary and metastatic lesion;
• Unwilling to accept potential related adverse events caused by treatment for primary and metastatic lesion;
• 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;
• Had other severe disorders, such as:
• Unstable cardiac disease,
• Myocardial infarction less than 6 months prior to enrollment,
• Clinically significant cardiac failure requiring treatment, defined as New York Heart Association (NYHA) class III,
• Uncontrolled hypertension,
• Severe neurological or psychological disorder including dementia or epilepsy,
• Uncontrolled active infection,

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; Goserelin; Triptorelin Pamoate; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Abiraterone Acetate; apalutamide; enzalutamide; Radiotherapy; Radiosurgery; Protons; Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Dingwei Ye, Doctoral

  Fudan University

  STUDY CHAIR

Central Study Contacts

Bo Dai, Doctoral

CONTACT

8618017312570; bodai1978@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 28, 2022
• Study Start: April 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)