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Prostate Cancer clinical trials

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NCT ID: NCT04845503 Active, not recruiting - Prostate Cancer Clinical Trials

Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

SMILE
Start date: March 25, 2021
Phase: N/A
Study type: Interventional

As the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. In addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in the non-metastatic primary situation. However, radiotherapy usually stretches over a period of several weeks (7 to 8 weeks) during which the patient receives irradiation on a daily basis. For this reason and for radiobiological considerations the total treatment time is increasingly shortened. It has been shown in several randomized phase III studies that shorting radiotherapy to about 4 weeks by increasing the single dose (so-called hypofractionation) is possible. Meanwhile there is also more data on extreme hypofractionation (max. 10 radiation sessions) available, however often times, extensive preparations are necessary (such as the invasive introduction of markers into the prostate). The current, prospective, non-randomized, multicentric, Phase II SMILE study is now testing whether the MRI-guided radiotherapy with a greatly shortened radiotherapy of the prostate over 5 radiation sessions is possible and safe.

NCT ID: NCT04842890 Active, not recruiting - Prostate Cancer Clinical Trials

Phase II Study of Pencil Beam Scanning Proton Stereotactic Body Radiation Therapy for Prostate Cancer

Start date: January 8, 2021
Phase: Phase 2
Study type: Interventional

This is a single arm phase II study of image-guided pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day) for patients with low- and intermediate-risk prostate cancer. The primary aim is to assess GU/GI toxicity of proton SBRT and compare this to historic outcomes associated with photon-based prostate SBRT. The primary endpoint is 2-year grade 3+ GU/GI toxicity free rate by CTCAE v5.0, which is expected to be ≥95%. Toxicity will be evaluated by the treating radiation oncologist at least once during SBRT, then following SBRT at 1, 3, 6, 12, 18, and 24 months. The treatment will be considered safe if grade 3 or higher GU/GI toxicity free rate at 2 years is >85% (95% rate expected with a 10% non-inferiority margin). The accrual goal is 61 patients over 3 years. To ensure that unexpected significant toxicity is identified, all grade 3 or higher toxicities will be reported to the study PI and the trial will stop accruing if at any point 4 or more patients experience a grade 3 or higher toxicity after completing SBRT. This is felt to be conservative given the vast experience with photon SBRT at this dose with an expected G3+ toxicity of ~5%. Secondary objectives are to examine patient-reported urinary, gastrointestinal, sexual, and financial outcomes using IPSS, EPIC-26, and COST questionnaires at the same follow-up timepoints as above. Baseline measures of these domains will be obtained prior to treatment as well. Clinical outcomes will also be evaluated with PSA measured at each follow-up, as well as prostate MRI and biopsies at 2 years. Patients will be followed for at least 2 years to determine rates of PSA relapse, salvage treatment, development of metastases, death from prostate cancer, and overall survival. A dosimetric comparison will be performed where each patient will be planned for proton and photon SBRT to determine possible advantages of proton SBRT.

NCT ID: NCT04831307 Active, not recruiting - Prostate Cancer Clinical Trials

68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical

Start date: August 30, 2021
Phase: N/A
Study type: Interventional

This is a preliminary evaluation of a radiotracer's biodistribution in human subjects. It is a prospective, single-centre, open-label, single group assignment interventional study. Prostate cancer is very common, and PSMA imaging is currently the most accurate means of localizing these tumours. The goal is to evaluate the biodistribution and safety of [68Ga]HTK03149 PET/CT for prostate cancer imaging.

NCT ID: NCT04821622 Active, not recruiting - Prostate Cancer Clinical Trials

Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.

NCT ID: NCT04782713 Active, not recruiting - Prostate Cancer Clinical Trials

Smart Prostate Specific Antigen (PSA) Screening Study

Start date: December 17, 2021
Phase: N/A
Study type: Interventional

This intervention includes the introduction of the Prostate Cancer Working Group (PCWG )Smart PSA Screening Guidelines and implementation of patient navigation/ care coordination for men with elevated PSA (>4.0 ng/mL). The guidelines include: 1. What age to start? 2. How often to repeat screening? 3. What age to stop? 4. What PSA threshold should trigger a biopsy referral?

NCT ID: NCT04751929 Active, not recruiting - Prostate Cancer Clinical Trials

Abemaciclib With or Without Atezolizumab for mCRPC

Start date: August 20, 2021
Phase: Phase 2
Study type: Interventional

This trial is testing whether a molecularly targeted chemotherapy drug called abemaciclib and an immunotherapy drug called atezolizumab, alone or in combination, are effective in shrinking or preventing the growth of metastatic prostate cancer. The trial is also testing the safety of the combination of abemaciclib with atezolizumab.

NCT ID: NCT04742361 Active, not recruiting - Prostate Cancer Clinical Trials

Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer

Start date: September 8, 2021
Phase: Phase 3
Study type: Interventional

This study evaluates the diagnostic performance and safety of [18F]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

NCT ID: NCT04733768 Active, not recruiting - Prostate Cancer Clinical Trials

18F-PSMA-1007 PET/CT Imaging in Patients With Biochemically Recurrent or High-risk Prostate Cancer

Start date: August 31, 2021
Phase: Phase 2
Study type: Interventional

Single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and diagnostic accuracy will be assessed. For diagnostic accuracy comparison will be made to a contemporary (within 10 days) conventional imaging study (bone scan and CT scan).

NCT ID: NCT04701021 Active, not recruiting - Prostate Cancer Clinical Trials

TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy

Start date: February 17, 2021
Phase: Phase 1
Study type: Interventional

This is a phase I, dose selection study of safety and effect of different doses of TENDU vaccine, a therapeutic peptide conjugate vaccine, in patients with relapse after primary radical prostatectomy.

NCT ID: NCT04693169 Active, not recruiting - Prostate Cancer Clinical Trials

[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

To investigate the radioactive uptake of [Al 18 F]PSMA137 in PCa patients, and evaluate the ability of [Al 18 F]PSMA137 to detect PSMA overexpression in PCa patients (especially those with recurrent or advanced PCa).To provide an approach for screening patients high expression of PSMA, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.