Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Radium Ra 223 dichloride

Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals

Radium Ra 223 Dichloride

All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.

Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:

* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)

Radiation

This is a phase IIa, open label, single arm, and prospective study of hormone therapy-naïve men with oligometastatic prostate cancer to the bone. The study will test if treating the primary tumor sites and 5 or fewer sites of bone-only metastasis with external beam radiation with concomitant systemic Radium-223 will reduce the utilization of androgen deprivation therapy, improve QOL and improve OS over a the comparator cohort of SWOG intermittent ADT historic cohort.

This is a phase IIa, open label, single arm, prospective study

Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone

A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone

To determine if 20% of ADT naïve men treated with concurrent EBRT and Radium-223 will not require ADT for progression by 15 months.

Determine the hormone-therapy free survival time for men treated with concurrent EBRT and Radium-223 and determine if it is a 30% risk reduction over the SWOG intermittent ADT historic cohort

To evaluate health related quality of life (QOL) as scored by the 50 item Expanded Prostate Inventory Composite (EPIC) EPIC urinary, bowel, sexual and hormonal domains.

EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health-related quality of life.

To evaluate health related quality of life (QOL). The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) will be used to assess general function and well-being.

The raw score for each PROMIS instrument is converted to a T-score on a scale of 0-100. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T score represents more of the concept being measured. For negatively worded concepts like Anxiety, a T score of 60 is one SD worse than average. By comparison, an Anxiety T score of 40 is one SD better than average. However, for positively worded concepts like Physical Function Mobility, a T score of 60 is one SD better than average while a T score of 40 is one SD worse than average.

Documentation of complications associated with bone metastases and may include (but not limited to) fractures, spinal cord compression, bone pain, and hypercalcemia.

Time elapsed from baseline PSA to double in value.

Evaluate overall survival at 2 years relative to the SWOG intermittent ADT historic cohort.

Endpoint: Patients will be followed for survival for two years after study enrollment

Bayer

University of Utah

Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals

Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.

Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:

* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)

Radium Ra 223 Dichloride and Radiation, All Patients

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Clinicaltrials.gov and CTRP Specialist

Count of Participants Requiring Androgen Deprivation Therapy (ADT) Use at 15 Months

8 of 20 total patients did not begin ADT while on study, so 12 of 20 patients were evaluated for this measure

Median Time From Start of Study Therapy to Start of ADT

Urinary Summary Score

Bowel Summary Score

Sexual Summary Score

Hormonal Summary Score

Of the 20 total participants, 10 completed the EPIC questionnaire at the End of Treatment timepoint

Spots Global Cancer Trial Database for Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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