Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Carcinoma

Prostatic Neoplasms

Adenocarcinoma

Recurrence

Neoplasms, Second Primary

Disease Attributes

Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.

Patients with nodal metastases undergo salvage oligometastasectomy.

Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.

Undergo hypofractionated radiation therapy

Hypofractionated Radiation Therapy

Intensity-Modulated Radiation Therapy

Metastasectomy

Quality-of-Life Assessment

Questionnaire Administration

Stereotactic Body Radiation Therapy

Alejandro Sanchez

This phase II trial studies how well surgery and radiation therapy work in treating patients with prostate cancer that has come back or spread to other parts of the body. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures, such as oligometastasectomy, may remove tumor cells that have spread to other parts of the body. Surgery and radiation therapy may work better in treating patients with prostate cancer that has come back or spread to other parts of the body.

PRIMARY OBJECTIVES:

I. To assess response to treatment of oligometastatic disease.

SECONDARY OBJECTIVES:

I. To assess additional measurements of response to treatment of oligometastatic disease.

II. To assess prostate-specific antigen (PSA) progression free-survival following treatment of oligometastatic disease.

III. To assess time to disease recurrence following treatment of oligometastatic disease.

IV. To assess time to initiation of antiandrogen therapy (ADT) for metastatic prostate cancer following treatment of oligometastatic disease.

V. To assess the rate of undetectable PSA following treatment of oligometastatic disease in subjects who have previously undergone prostatectomy.

VI. To assess safety. VII. To assess the impact of study treatment on change in quality of life over three years.

Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer

Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (SOAR)

Defined according to Prostate Cancer Working Group (PCWG3) criteria as the proportion of patients achieving a PSA decline \>= 50% at 6 months after completion of treatment (salvage + - adjuvant). All study data will use descriptive statistics and will be exploratory only.

Assessed according to PCWG3 criteria. All study data will use descriptive statistics and will be exploratory only.

Time from study enrollment until the date of confirmed radiographic disease progression as defined by RECIST 1.1 and PCWG3.

All study data will use descriptive statistics and will be exploratory only.

Patients previously treated with prostatectomy evaluate the proportion of patients whose PSA remains =\< 0.2 ng/mL after 6 and 12 months following completion of treatment (salvage + - adjuvant). All study data will use descriptive statistics and will be exploratory only.

Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All study data will use descriptive statistics and will be exploratory only.

Quality of Life (QOL) questionnaires (FACT-P and Expanded Prostate Cancer Index Composite EPIC-26) administered at screening, response assessment visit, and each follow up visit.

University of Utah

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Anticoagulants

Bone Density Conservation Agents

Amino Acids

Gallium 68 PSMA-11

Edetic Acid

Pentetic Acid

Chelating Agents

Calcium

Calcium, Dietary

Radiopharmaceuticals

Lysine

Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Computed Tomography (CT) scan

68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.

68Ga-PSMA-11

Positron Emission Tomography (PET)

Andrei Iagaru, MD

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA

Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.

68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.

Positive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.

Scan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows.

* 0.2 to \< 0.5
* 0.5 to \< 1.0
* 1.0 to \< 2.0
* 2.0 to \< 5.0
* ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.

Andrei Iagaru

Professor of Radiology

Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.

* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT

Diagnostic (68Ga-PSMA-11 PET/CT)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Andrei Iagaru, Professor of Radiology (Nuclear Medicine)

Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT

Sensitivity

Specificity

68Ga-PSMA-11 PET/CT Sensitivity and Specificity

Positive predictive value (PPV)

Negative predictive value (NPV)

68Ga-PSMA-11 PET/CT Predictive Value by Region

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.2 to < 0.5 ng/m?

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL

Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level

Overall Study

Immune System Diseases

Hypersensitivity

Androgens

Hormones

Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy.

Richard Casey, M.D.

Alvaro Morales, M.D.

This Phase IV observational trial is intended to identify patients who are failing GnRH agonist therapy as evidenced by a rising PSA and who have yet to initiate secondary manoeuvres involving antiandrogens. This group may include both non-metastatic as well as metastatic patients. The trial will determine if these patients will benefit from switching to Degarelix. It will assess the effect of Degarelix's direct mode of action on androgen levels and whether continuous use of Degarelix improves disease progression.

As per the CUA Guidelines for the Management of CRPC, because the androgen receptor remains active in most patients who have developed castration resistant disease, it is recommended that ADT should be continued (LEVEL 3, GRADE C). Therefore, it is logical to continue patients on Degarelix throughout the castrate resistant period. This will allow for the gathering of data that is currently unknown within this setting, such as the effect of combined treatment with antiandrogens as well as chemotherapy and other castrate resistant treatments.

This trial will include hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists but prior to use of secondary hormonal treatments such as antiandrogens. The purpose of this trial is to determine the effect of Degarelix's direct mode of action on androgen levels and whether continuous use of Degarelix improves disease progression.

This is an open-label, multi-centre, Phase IV observational trial with s.c. injections of Degarelix one-month depot in patients with advanced prostate cancer.

The visit frequency is once a month (28-day intervals), with eCRF data entry at every 4 months. All patients will be treated with a one-month starting dose followed by 23 monthly maintenance doses for a duration of 672 days. The primary endpoints will be evaluated after 24 treatment months.

In total, 25 visits are scheduled for all patients.

Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists

Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)

To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists

To evaluate testosterone, bio available testosterone (calculated), prostate serum antigen (PSA), luteinizing hormone (LH) , follicle-stimulating hormone (FSH), dihydrotestosterone (DHT) and dehydroepiandrosterone (DHEA) before and after switching to Degarelix and over time

To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression)

To evaluate how long patients are on degeralix prior to demonstrating biochemical disease progression (time to PSA failure)

To evaluate how long patients are on degeralix before they develop metastases (non-metastatic patients)

Eevaluate how long patients have been on degeralix before initiating chemotherapy.

Evaluate how long patients are on degeralix before initiating anti-androgen use as well as response to anti-androgen use

To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer	NCT03796767	Recurrent Prost... Metastatic Mali... Metastatic Mali... Oligometastasis Prostate Adenoc... PSA Failure	Hypofractionate... Intensity-Modul... Metastasectomy Quality-of-Life... Questionnaire A... Stereotactic Bo...	18 Years -	University of Utah
68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment	NCT02673151	Prostate Adenoc... PSA Failure Recurrent Prost...	Computed Tomogr... 68Ga-PSMA-11 Positron Emissi...	18 Years -	Stanford University
Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists	NCT01366053	Prostate Cancer		18 Years -	CMX Research
Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer	NCT03796767	Recurrent Prost... Metastatic Mali... Metastatic Mali... Oligometastasis Prostate Adenoc... PSA Failure	Hypofractionate... Intensity-Modul... Metastasectomy Quality-of-Life... Questionnaire A... Stereotactic Bo...	18 Years -	University of Utah

Spots Global Cancer Trial Database for psa failure

Every month we try and update this database with for psa failure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for psa failure

Every month we try and update this database with for psa failure cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for psa failure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.