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Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer

Jacksonville, FL
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Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, FL

Open for enrollment
View complete study & contact information

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Site IRB:
24-010825

NCT ID:
NCT07073794

Sponsor Protocol Number:
MC240507

Mayo Clinic Location	Status	Contact
Jacksonville, FL	Open for enrollment	View complete study & contact information

Highly Selective CDK7 Inhibitor Q901 In Selected Advanced Solid Tumors

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Highly Selective CDK7 Inhibitor Q901 In Selected Advanced Solid Tumors

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

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Site IRB:
22-009877
NCT ID:
NCT05394103
Sponsor Protocol Number:
QRNT-009

Study Of JANX007 In Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Study Of JANX007 In Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

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Site IRB:
25-004536
NCT ID:
NCT05519449
Sponsor Protocol Number:
PSMA-007-001

Study Of Zanzalintinib In Combination With Immuno-Oncology Agents In Participants With Solid Tumors

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Study Of Zanzalintinib In Combination With Immuno-Oncology Agents In Participants With Solid Tumors

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.

In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
22-006280
NCT ID:
NCT05176483
Sponsor Protocol Number:
XL092-002

A Clinical Study Of Ifinatamab Deruxtecan (I-DXd) In People With Metastatic Prostate Cancer (MK-2400-001)

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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A Clinical Study Of Ifinatamab Deruxtecan (I-DXd) In People With Metastatic Prostate Cancer (MK-2400-001)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, AZ	Open for enrollment	View complete study & contact information
Jacksonville, FL	Open for enrollment
Rochester, MN	Open for enrollment

Print study details

Site IRB:
25-006761
NCT ID:
NCT06925737
Sponsor Protocol Number:
2400-001

Study Of PSMA-targeted Therapy And Androgen Receptor Suppression In Low-volume Metastatic ProstatE Cancer: SPARKLE Trial

Rochester, MN
- See Details
Study Of PSMA-targeted Therapy And Androgen Receptor Suppression In Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to Evaluate whether ¹⁷⁷Lu-PSMA-617 + (iADT) ± (iAA+P) can lower 18-month radiographic progression-rates compared (iADT) ± (iAA+P)in patients with low-volume metastatic hormone-sensitive prostate cancer (mHSPC).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
25-008953

NCT ID:
NCT07650240

Sponsor Protocol Number:
MC250507
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation In PSMA Positive OMPC.

Rochester, MN
- See Details
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation In PSMA Positive OMPC.
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  3
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, MN

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
23-007167

NCT ID:
NCT05939414

Sponsor Protocol Number:
CAAA617D12302

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Search Results 1-7 of 7 for

Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer

Highly Selective CDK7 Inhibitor Q901 In Selected Advanced Solid Tumors

Study Of JANX007 In Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Study Of Zanzalintinib In Combination With Immuno-Oncology Agents In Participants With Solid Tumors

A Clinical Study Of Ifinatamab Deruxtecan (I-DXd) In People With Metastatic Prostate Cancer (MK-2400-001)

Study Of PSMA-targeted Therapy And Androgen Receptor Suppression In Low-volume Metastatic ProstatE Cancer: SPARKLE Trial

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation In PSMA Positive OMPC.

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