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Tests treatment safety and results for Biochemical Recurrence of Malignant Neoplasm of Prostate
Official title 68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
ClinicalTrials.gov ID: NCT05847348
What this study is testing
What is 68Ga-PSMA-11?
68Ga-PSMA-11 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biochemical recurrence of malignant neoplasm of prostate.
Also referred to as Illucix, gallium Ga 68 Gozetotide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Are able to understand and provide written informed consent document.
- Are Chinese males aged ≥ 18 years.
- Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced...
- Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
- Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
You likely can't join if
- Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that...
- Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
- Are participating or plan to participate in any drug or device clinical study during the study period.
- Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
- Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
- Have prior history of salivary gland disease or Paget's disease.
See the full eligibility criteria
- Are able to understand and provide written informed consent document.
- Are Chinese males aged ≥ 18 years.
- Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).
- Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
- Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
- Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
- Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
- Are willing and able to comply with scheduled
- Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
- Are participating or plan to participate in any drug or device clinical study during the study period.
- Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
- Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
- Have prior history of salivary gland disease or Paget's disease.
- Have a history of fracture and anemia within the last year.
- Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.
- Is deemed not suitable for participating in this trial in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Guangzhou, China
- Shanghai, China
- Sichuan, China
- Wuhan, China
- Wuxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changsha, China; Guangzhou, China; Shanghai, China; Sichuan, China; Wuhan, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.