In 2007 a Norwegian cancer therapeutics company, Algeta, presented data from a phase II study that showed a remarkable two-year survival advantage with its investigational drug, Alpharadin (radium-223), when used as a as a treatment for castrate resistant prostate cancer (CRPC).

The clinical trial involved 64 men with CRPC and showed that more than twice as many men receiving Alpharadin were still alive (10men of 33men) two years following start of treatment compared to those that receive placebo (4 men of 31men).

Previous data from the trial, presented earlier at an ASCO meeting and in the Lancet Oncology, has also shown that Alpharadin also significantly reduces levels of prostate-specific antigen (PSA), and other relevant biomarkers.

The treatment regime consisted of four injections of Alpharadin. It was reported that the drug was well tolerated during the 12-week treatment period, and an extended treatment period may further delay disease progression.

Algeta’s CEO, Dr. Thomas Ramdahl said: “Alpharadin continues to demonstrate a very positive clinical effect in the treatment of prostate cancer and our preparations to begin pivotal Phase III trials with Alpharadin for the treatment of HRPC in 2008 remain on schedule.”

This very exciting new drug has received minimal notice by members of the prostate cancer community and was only called to my attention by a member of Malecare’s internet advanced prostate cancer support group. (to join this group go to: https://healthunlocked.com/advanced-prostate-cancer

I became curious about what trials might be on-going and was very pleased to see there are many active trials for men with castrate resistant prostate cancer.

The following is a list of active and recruiting trials from www.clinical trials.gov. Search for Alpharadin to find these trials, including contact information, exclusions and inclusion criteria:

1) Active, not recruiting – Study of Radium-223 for the Palliation of Painful Bone Metastases in Hormone Refractory Prostate Cancer (HRPC) Patients
Conditions: Hormone Refractory Prostate Cancer; Bone Metastases
Drug: Alpharadin (Radium-223)

2) Not yet recruiting – A Study of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
Conditions: Bone Metastases; Castration-Resistant Prostate Cancer
Interventions: Drug: Alpharadin® (Radium-223 chloride) + docetaxel; Drug: Docetaxel

3) Recruiting – A Phase III Study of Alpharadin (Radium-223)in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Conditions: Hormone Refractory Prostate Cancer; Bone Metastases
Interventions: Drug: Alpharadin (Radium-223); Drug: Placebo

4) Active, not recruiting Alpharadin™ Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton
Conditions: Prostate Cancer; Metastases; Pharmacokinetics
Intervention: Drug: Radium-223 chloride (Alpharadin™ )

5) Active, not recruiting – Radium-223 in Patients With Hormone Refractory Prostate Cancer (HRPC) and Skeletal Metastases
Conditions: Hormone Refractory Prostate Cancer; Bone Metastases
Intervention: Drug: Alpharadin TM (Radium-223)

6) Active, not recruiting – A Placebo-Controlled Phase II Study of Bone-Targeted Radium-223 in Symptomatic Hormone-Refractory Prostate Cancer
Conditions: Prostate Cancer; Neoplasm Metastasis
Intervention: Drug: Alpharadin (Radium-223)

7) Active, not recruiting A Dose Finding Study of Radium-223 for Prostate Cancer Patients With Bone Metastases
Conditions: Prostate Cancer; Neoplasm Metastasis
Intervention: Drug: Radium-223 (Alpharadin )

Alpharadin looks like it has significant potential and I would urge that you look into participating in one of the trials that is still recruiting. I will continue to monitor any results as they become known.

Joel T Nowak, MA, MSW