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Prostate CancerPhase 2NCT05212857

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

A Phase 2 study testing Leuprolide acetate, Goserelin acetate and Triptorelin acetate in people with Prostate Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Leuprolide acetate, Goserelin acetate and Triptorelin acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
Apr 2022to Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;
  • Willing and expected to comply with treatment and follow up schedule.
  • Life expectancy > 10 years.

Who cannot join

  • 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;
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  • 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,
  • Acute gastric ulcer,
  • Hypercalcemia,
  • Chronic obstructive pulmonary lung disease requiring hospitalization,
  • Any other significant disorders that in the investigator's opinion means the participant is unfit for any of the study treatments;
  • Had participated in other clinical trial before enrollment.
  • Had contraindications to radiotherapy or unsuitable for radical radiotherapy evaluated by radiologists and physicists.

Trial locations and contacts

1 site in 1 country.

Bo Dai, Doctoral contact

8618017312570

bodai1978@126.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Dai Bo, Doctor, 8621-64175590, bodai1978@126.com

    Recruiting

Other trials in China

About this study

Official title: Long-term Effects of Enhanced Systemic Therapy and Tumor-directed Therapy for Newly Diagnosed Oligometastatic Prostate Cancer Confirmed by Conventional Imaging Modality: a Prospective, Single-arm Study.

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.

Read the 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
Being tested
Leuprolide acetate, Goserelin acetate, Triptorelin acetate, Degarelix acetate, Abiraterone acetate
Keywords
prostate cancer, radical prostatectomy, androgen deprivation therapy, local treatment, radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leuprolide acetateDrug

    Also called Enantone

    Given subcutaneously or as an injection

  • Goserelin acetateDrug

    Also called Zoladex

    Given subcutaneously or as an injection

  • Triptorelin acetateDrug

    Also called Diphereline

    Given subcutaneously or as an injection

  • Degarelix acetateDrug

    Also called Firmagon

    Given subcutaneously or as an injection

  • Abiraterone acetateDrug

    Also called ZYTIGA

    Given orally

  • ApalutamideDrug

    Also called ERLEADA

    Given orally

  • EnzalutamideDrug

    Also called Xtandi

    Given orally

  • Local treatment for primary lesionProcedure or surgery

    Radical prostatectomy to remove prostate primary lesion

  • Radiotherapy for primary lesionRadiation

    Radical radiotherapy for primary lesion

  • Radiotherapy for metastatic lesionRadiation

    Also called Stereotactic body radiation therapy or proton and heavy ion radiation therapy

    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.

Study groups in NCT05212857
Study groupRoleWhat they receive
systemic treatment combined with radical treatment and radiotherapyExperimentalAll 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (3)

  1. Two years' overall survival (OS)

    Proportion of patients survived after two years' treatment.

    Measured: 2 years

  2. Two years' PSA progression-free survival (PSA-PFS)

    Proportion of patients with no observed PSA progression after two years' treatment. PSA progression is defined as a confirmed increase in the PSA level from the nadir value by ≥25% and by ≥2 ng/ml.

    Measured: 2 years

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

    Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). pCR is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm.

    Measured: 1 month after prostatectomy as local treatment for primary lesion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study startApr 2022 (estimated)
  3. Primary completionFeb 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212857
Sponsor's protocol ID
OMPCa-ENSURE
Status last verified
Mar 2022
First submitted
24 Dec 2021
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Leuprolide acetate, Goserelin acetate and Triptorelin acetate in people with Prostate Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bo Dai, Doctoral (8618017312570, bodai1978@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two years' radiographic progression-free survival (rPFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05212857.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.

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